
BE PROACTIVE. LEARN HERE.
RESEARCH
LINKS TO GET YOU STARTED.
PART A — STEM CELL PRODUCT REVIEWS AND TRIALS
-
-
Rash et al., Nature Medicine (2025)
-
In this small Phase 2a trial, 48 people with mild Alzheimer’s disease received laromestrocel—an intravenous, donor-derived MSC therapy—or placebo. Treatment showed promising signals for cognition, quality of life and reduced brain-volume loss.
-
Follow-up exploratory MRI analyses suggested reduced neuroinflammation, particularly in the hippocampus and temporal lobe. Larger trials are needed to confirm these findings.
-
Laromestrocel has FDA RMAT and Fast Track designations, but it is investigational and not FDA-approved.
-
-
This 2025 review examined stem cells and their exosomes as potential treatments for cognitive decline, Alzheimer’s and Parkinson’s disease.
-
Early laboratory and animal studies suggest they may reduce brain inflammation, protect nerve cells and support brain repair.
-
Exosomes may also help carry beneficial signals across the blood–brain barrier.
-
Results are promising, but larger human clinical trials are still needed to confirm safety and effectiveness.
-
-
https://www.mdpi.com/1999-4923/17/3/284
-
This 2025 review found that MSCs and their exosomes may reduce brain inflammation, protect nerve cells and support brain repair.
-
Early studies suggest potential benefits for cognitive decline, Alzheimer’s and Parkinson’s disease.
-
Most evidence comes from laboratory and animal research; larger human trials are still needed.
-
-
Shan et al. MSC-Derived Exosomes in Alzheimer's Disease Treatment. World J Stem Cells. 2025;17(8):109006.
-
This 2025 review found that MSC-derived exosomes may help clear amyloid-beta, reduce brain inflammation and support nerve-cell repair.
-
Early laboratory, animal and limited clinical research is encouraging, but larger human trials are needed to confirm safety and effectiveness.
-
-
Salehpour et al. Therapeutic Potential of MSC-Derived Exosomes in Neurological Disorders. Front Cell Neurosci. 2024;18:1427525.
-
This 2025 review found that MSC-derived exosomes may help clear amyloid-beta, reduce brain inflammation and support the repair of damaged nerve cells.
-
Early research is promising, but larger human clinical trials are needed to confirm safety and effectiveness.
-
-
Advances in therapies using MSCs and exosomes in peripheral nerve injury. Neural Regeneration Research. 2025;20(11):3151–3171.
-
This 2025 review found that MSCs and their exosomes may support peripheral nerve repair by reducing inflammation and promoting blood-vessel growth, axon regrowth and remyelination.
-
Early research is promising, but these treatments remain experimental and require larger human clinical trials.
-
-
NCT07295067 — intrathecal injection of MSC-derived extracellular vesicles for syringomyelia. Open-label, single-arm, dose-escalation Phase 1, Xuanwu Hospital, Beijing.
-
Bonafede R, Mariotti R. Extracellular vesicles in neurodegenerative diseases: current evidence and future perspectives. Front Neurosci. 2017.
-
Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020.
-
-
-
Acute Ischemic Stroke
-
TREASURE (NCT02961504). Houkin K, et al. Allogeneic stem cell therapy for acute ischemic stroke: the Phase 2/3 TREASURE randomized clinical trial. JAMA Neurol. 2024;81(2):154–162. – 206 patients, 44–48 sites in Japan, MultiStem (invimestrocel/HLCM051), a bone marrow–derived allogeneic multipotent adult progenitor cell product, IV within 18–36 hours. Safe but did not improve short-term outcomes. Exploratory subgroup signals in large infarcts and younger patients, uncorrected for multiplicity.
-
MASTERS. Hess DC, et al. Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled Phase 2 trial. Lancet Neurol. 2017;16(5):360–368.
-
MASTERS-2 — Phase 3, US/Europe/Asia-Pacific. Check ClinicalTrials.gov for current status and any combined TREASURE + MASTERS-2 analysis.
-
AMASCIS. de Celis-Ruiz E, et al. Final results of allogeneic adipose tissue–derived mesenchymal stem cells in acute ischemic stroke (AMASCIS): a Phase 2, randomized, double-blind, placebo-controlled, single-center pilot trial.
-
Chung JW, et al. Efficacy and safety of intravenous mesenchymal stem cells for ischemic stroke. Neurology. 2021;96:e1012–e1023. (Autologous — included here only as context; excluded per your criteria.)
-
Meta-analysis: Efficacy and safety of stem cell therapy for acute and subacute ischemic stroke: a systematic review and meta-analysis. Sci Rep. 2025;15. doi:10.1038/s41598-025-04405-6
-
-
Multiple Sclerosis
-
MESEMS. Uccelli A, et al. Safety, tolerability, and activity of mesenchymal stem cells versus placebo in multiple sclerosis (MESEMS): a Phase 2, randomised, double-blind crossover trial. Lancet Neurol. 2021;20(11):917–929. – 144 patients, 15 sites, 9 countries. Safe, but no reduction in gadolinium-enhancing lesions at 24 weeks vs placebo. – ⚠️ This trial used autologous bone marrow–derived MSCs and therefore falls outside your inclusion criteria. It is listed because it is the largest and most rigorous MSC-in-MS trial to date and because omitting it would leave a misleadingly favorable picture of the indication.
-
Uccelli A, et al. MESEMS protocol paper. Trials. 2019;20:263.
-
Llufriu S, et al. Randomized placebo-controlled Phase 2 trial of autologous mesenchymal stem cells in multiple sclerosis. PLoS One. 2014;9(12):e113936. (Autologous — context only.)
-
For allogeneic MSC in MS, search ClinicalTrials.gov for UC-MSC/Wharton's jelly MS trials; the published allogeneic evidence base is currently thin and dominated by small single-arm studies
-
-
Hair Restoration
-
Al Ameer et al. Exosomes and Hair Regeneration: A Systematic Review. Clin Cosmet Investig Dermatol. 2025;18:2215–2227.
-
This 2025 systematic review found that exosome treatments were associated with increased hair density, thickness and growth across several types of hair loss.
-
Results are promising, but studies were small and used different products and treatment methods. Larger controlled trials are needed
-
Exosomes and hair regeneration: a systematic review of clinical evidence. Clin Cosmet Investig Dermatol. 2025. – 11 clinical studies. Consistent reported improvement in hair density and thickness, but only two were randomized controlled trials, and sources/protocols were not standardized.
-
Ersan M, Ozer E, Akin O, Tasli PN, Sahin F. Effectiveness of exosome treatment in androgenetic alopecia: outcomes of a prospective study. Aesthetic Plast Surg. 2024;48(21):4262–4271. doi:10.1007/s00266-024-04332-3
-
Amini F, Teh JJ, Tan CK, Tan ESS, Ng ESC. A pilot randomized controlled trial evaluating the efficacy of an exosome-containing plant extract formulation for treating male alopecia. Life. 2025;15(3):500. – 20 male participants, Norwood 2–3. Note this is a plant-extract formulation, not an MSC-derived product — an important distinction patients rarely catch.
-
Dehghani L, Rostamirad S, Asilian A, et al. Efficacy of placental-derived mesenchymal stem cell exosome therapy in treating androgenetic alopecia: a clinical trial study. 2024.
-
Shin H, Yoo B, Lee S. Clinical efficacy and safety of topically applied exosomes for hair growth. 2022.
-
Active recruiting RCTs: NCT07203599 (UC-MSC exosomes in young men, Phase 1/2, randomized, Shenzhen People's Hospital) and NCT07373054 (UC-MSC exosomes vs 5% minoxidil, randomized, quadruple-masked, Fujian Medical University Union Hospital).
-
-
-
Musculoskeletal Conditions and Joint Pain
-
Frontiers in Pharmacology. MSC-Derived Exosomes for Knee Osteoarthritis: Systematic Review and Meta-Analysis. 2025. doi:10.3389/fphar.2025.1588841
-
This 2025 meta-analysis of 29 animal studies found that MSC-derived exosomes reduced joint inflammation and cartilage breakdown while supporting cartilage repair in knee osteoarthritis.
-
Results are promising, but the findings are based on rat models and must be confirmed in human clinical trials.
-
-
Bone Joint Res. ADSC Exosomes for Osteoarthritis. 2025;14(12):1092–1108.
-
This 2025 review found that adipose-derived stem cell exosomes may reduce joint inflammation, protect cartilage cells and support cartilage regeneration in osteoarthritis.
-
Most exosome findings come from laboratory and animal studies; human trials are still needed to confirm safety and effectiveness
-
-
Cartistem Phase 3. Lim HC, Park YB, Ha CW, Cole BJ, et al.
-
Allogeneic umbilical cord blood–derived mesenchymal stem cell implantation versus microfracture for large, full-thickness cartilage defects in older patients: a multicenter randomized clinical trial and extended 5-year clinical follow-up.
-
Orthop J Sports Med. 2021;9(1). doi:10.1177/2325967120973052 – UCB-MSC + 4% hyaluronic acid hydrogel. Improved cartilage grade at second-look arthroscopy at 48 weeks and more durable pain/function improvement than microfracture. Industry-sponsored (Medipost).
-
Sadri B, et al. Cartilage regeneration and inflammation modulation in knee osteoarthritis following injection of allogeneic adipose-derived mesenchymal stromal cells: a Phase 2, triple-blinded, placebo-controlled, randomized trial. Stem Cell Res Ther. 2023;14:162. doi:10.1186/s13287-023-03359-8 – 40 patients, 100×10⁶ allogeneic AD-MSCs intra-articular vs control.
-
Kasagga A, et al. Autologous versus allogeneic adipose-derived mesenchymal stem cell therapy for knee osteoarthritis: a systematic review, pairwise and network meta-analysis of randomized controlled trials. Cureus. 2025;17(4):e82713. – Eight RCTs, Kellgren-Lawrence Grade II–IV. Useful for patients asking specifically about donor vs own cells; note the finding favored high-dose autologous for sustained 12-month pain relief.
-
Review: Clinical research progress of umbilical cord blood mesenchymal stem cells in knee articular cartilage repair. Medicine (Baltimore). 2025;104(6).
-
-
-
Chronic Low Back Pain / Degenerative Disc Disease
-
MSB-DR003 (NCT02412735). Phase 3, 404 patients, single intradiscal injection of rexlemestrocel-L + hyaluronic acid vs saline, 36-month follow-up. Reported durable pain reduction and >3-fold increase in opioid cessation at 36 months among 168 baseline opioid users (p=0.008). Long unpublished in peer-reviewed form — verify current publication status.
-
Amirdelfan K, et al. Allogeneic mesenchymal precursor cells for chronic low back pain associated with degenerative disc disease: a prospective, randomized, controlled 36-month study. Spine J. 2021;21(2):212–230. (NCT01290367, 100 patients.)
-
MSB-DR004 — confirmatory pivotal Phase 3, ≥300 patients, single intradiscal injection vs sham, 12-month primary endpoint. Recruitment target reached April 2026; 300 patients treated as of July 2026. Top-line results expected mid-2027. RMAT designation granted. – This is currently one of the more realistic near-term enrollment opportunities for patients in this indication; check ClinicalTrials.gov for site status.
-
-
Fertility
-
Wang et al. Mechanisms and Applications of MSC Exosomes in Enhancing Fertility. Stem Cell Res Ther. 2025. doi:10.1186/s13287-025-04729-0
-
This 2025 review found that MSC-derived exosomes may support fertility by reducing inflammation and oxidative stress and promoting the repair of ovarian, uterine and testicular tissues.
-
Most evidence comes from laboratory and animal studies; human clinical trials are needed to confirm safety and effectiveness.
-
-
MSC-Derived EVs for Primary Ovarian Insufficiency: Systematic Review and Meta-Analysis. J Ovarian Res. 2024. doi:10.1186/s13048-024-01513-1
-
This 2024 analysis of 29 preclinical studies found that MSC-derived extracellular vesicles increased ovarian follicle numbers and improved hormone levels and ovarian function in models of primary ovarian insufficiency.
-
Results are promising, but the evidence comes from animal studies and must be confirmed in human clinical trials.
-
-
Park et al. Fertility Protection Using MSC Exosomes to Prevent Chemotherapy-Induced Ovarian Damage. Am J Obstet Gynecol. 2024;231(1):111.e1–111.e18.
-
In this 2024 mouse study, MSC-derived exosomes given before chemotherapy helped protect ovarian function, preserve healthy follicles and reduce ovarian cell damage.
-
The findings suggest potential for fertility protection, but this approach has not yet been proven safe or effective in humans.
-
-
Graft-versus-Host Disease (GvHD): The most mature MSC indication and the only one with U.S. approval.
-
Le Blanc K, et al. Treatment of severe acute graft-versus-host disease with third party haploidentical mesenchymal stem cells. Lancet. 2004;363(9419):1439–41. – The index case: a 9-year-old boy with steroid-refractory aGvHD treated with MSCs from his mother.
-
MSB-GVHD001 (NCT02336230). Multicenter, prospective, single-arm study of remestemcel-L in 54 pediatric patients with steroid-refractory aGvHD, Grade B–D, after allogeneic HSCT. This is the pivotal study supporting the Ryoncil BLA.
-
Kurtzberg J, et al. Publications on remestemcel-L in pediatric steroid-refractory aGvHD (search PubMed: "remestemcel-L pediatric graft-versus-host").
-
Note on regulatory history: FDA declined approval of remestemcel-L in 2020 and 2023 over potency-assay concerns before the December 2024 approval. An earlier-generation product (Prochymal) was found safe but with efficacy comparable to placebo in its original trials.
-
NCT05531266 — hUC-MSCs as first-line treatment for aGvHD (randomized, China).
-
NCT05855707 (HAPLO-GEL) — Wharton's jelly MSC as GvHD prophylaxis in haploidentical HSCT, dose-escalation Phase 1, Nancy, France.
-
NCT06149832 — hUC-MSC dressing for oral chronic GvHD.
-
Kordelas L, Rebmann V, Ludwig AK, et al. MSC-derived exosomes: a novel tool to treat therapy-refractory graft-versus-host disease. Leukemia. 2014;28(4):970–973. – The first-in-human MSC-exosome case report. Symptoms improved and PBMC secretion of IL-1β, TNF-α, and IFN-γ fell after the third application. N = 1. This single case is the origin of a great deal of downstream marketing; patients should know its size.
Crohn's Disease — Complex Perianal Fistula
-
ADMIRE-CD. Panés J, et al. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a Phase 3 randomised, double-blind controlled trial. Lancet. 2016;388(10051):1281–1290. – 212 patients, 49 hospitals across Europe and Israel, randomized to 120 million Cx601 cells or placebo plus standard of care. Basis for EMA approval of Alofisel.
-
Panés J, et al. Long-term efficacy and safety of Cx601 — 52-week and 104-week follow-up. Gastroenterology. 2018.
-
ADMIRE-CD II. Efficacy and safety of darvadstrocel in complex perianal fistulas and Crohn's disease: results from the global Phase 3 study. J Crohns Colitis. 2024;18(Suppl 1):i34–i35. – Important to include: this confirmatory global Phase 3 did not replicate the ADMIRE-CD primary endpoint result. Patients should see both.
-
Ciccocioppo R, Guadalajara H, Astori G, et al. Misconceptions, hurdles and recommendations regarding the use of mesenchymal stem/stromal cells in perianal Crohn disease. Cytotherapy. 2023;25(3):230–234.
Ulcerative Colitis
-
Lightner AL, et al. A Phase IB/IIA study of remestemcel-L, an allogeneic bone marrow-derived MSC product, for medically refractory ulcerative colitis: an interim analysis. Colorectal Dis. 2022. – Endoscopically delivered MSCs, 150 million cells vs placebo (2:1), interim data on first 6 patients.
-
NCT04543994 — full trial record, Cleveland Clinic, Phase 1/2, randomized.
Chronic Heart Failure / Cardiomyopathy
-
DREAM-HF (NCT02032004). Perin EC, et al. Randomized trial of targeted transendocardial mesenchymal precursor cell therapy in patients with heart failure. J Am Coll Cardiol. 2023;81(9):849–863. – 537 patients, randomized, double-blind, sham-controlled Phase 3 of rexlemestrocel-L. Improved LVEF at 12 months and reduced the composite of cardiovascular death, MI, or stroke over mean 30-month follow-up. The trial did not meet its original primary endpoint of heart failure–related MACE — an essential caveat when citing it.
-
Borow KM, Yaroshinsky A, Greenberg B, Perin EC. Phase 3 DREAM-HF trial of mesenchymal precursor cells in chronic heart failure: biological plausibility and flexible trial design. Circ Res. 2019;125(3):265–281.
-
POSEIDON. Hare JM, et al. Comparison of allogeneic vs autologous bone marrow–derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012;308(22):2369–79. – Directly relevant to your allogeneic-only scope: this trial compared the two head to head.
-
TRIDENT. Florea V, et al. Dose comparison study of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy. Circ Res. 2017;121(11):1279–1290.
-
RIMECARD (NCT01739777). Bartolucci J, et al. Safety and efficacy of intravenous umbilical cord–derived MSCs in heart failure with reduced ejection fraction. Circ Res. 2017;121(10):1192–1204. Randomized, triple-masked, Universidad de los Andes, Chile.
-
Acute MI. Gao LR, et al. Intracoronary infusion of Wharton's jelly–derived mesenchymal stem cells in acute myocardial infarction: double-blind, randomized controlled trial. BMC Med. 2015;13:162. 11 hospitals in China, ST-elevation AMI.
ARDS and COVID-19 Respiratory Failure
-
Lanzoni G, et al. Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: a double-blind, Phase 1/2a, randomized controlled trial. Stem Cells Transl Med. 2021;10(5):660–673. – 24 subjects randomized 1:1, two IV infusions of ~100×10⁶ UC-MSCs. No related SAEs. Survival 91% vs 42% (p=0.015); improved SAE-free survival and time to recovery. Small sample — frame accordingly.
-
Dilogo IH, et al. Umbilical cord mesenchymal stromal cells as critical COVID-19 adjuvant therapy: a randomized controlled trial. Stem Cells Transl Med. 2021;10(9):1279–1287. – 40 critically ill patients, four referral hospitals, Jakarta. 2.5× higher survival in the treatment arm.
-
STROMA-CoV-2. Monsel A, et al. Phase 2b, multicenter, double-blind, randomized, placebo-controlled trial of UC-MSCs in SARS-CoV-2–induced ARDS. – Negative for the primary endpoint (PaO₂/FiO₂ ratio change). Safety at day 28 was good.
-
Monsel A, et al. Long-term safety, respiratory function, and quality of life in the STROMA-CoV-2 cohort. Stem Cell Res Ther. 2024;15:103. doi:10.1186/s13287-024-03729-w – 6- and 12-month follow-up; no significant between-group differences in any endpoint.
-
Rajarshi K, et al. Further validation of the efficacy of MSC infusions for reducing mortality in COVID-19 patients with ARDS.
-
Sengupta V, Sengupta S, Lazo A, Woods P, Nolan A, Bremer N. Exosomes derived from bone marrow mesenchymal stem cells as treatment for severe COVID-19. Stem Cells Dev. 2020;29(12):747–754. (ExoFlo, Direct Biologics.)
-
Lightner AL, et al. Bone marrow mesenchymal stem cell–derived extracellular vesicle infusion for the treatment of respiratory failure from COVID-19: a randomized, placebo-controlled dosing clinical trial. CHEST. 2023;164(6). (NCT04493242, Phase 2.) – Report a mortality signal in patients aged 18–65. Sponsor-employed authors — disclosed and worth noting.
-
EXTINGUISH ARDS (NCT05354141) — global multicenter randomized, double-blind, placebo-controlled Phase 3 of ExoFlo in hospitalized adults 18–65 with moderate-to-severe ARDS of any etiology; ~320 patients. FDA authorized expansion beyond COVID etiology in 2023. The first cell- or cell-derived candidate in Phase 3 for all-cause ARDS. Check ClinicalTrials.gov for enrollment status and results posting.
-
Chu M, Wang H, Bian L, et al. Nebulization therapy with umbilical cord mesenchymal stem cell–derived exosomes for COVID-19 pneumonia. Stem Cell Rev Rep. 2022. – 7 patients (2 severe, 5 mild), aerosolized delivery, Wuxi, Jiangsu. No acute or secondary allergic reactions reported.
-
Shanghai Ruijin Hospital / Jinyintan Hospital: aerosolized hAMSC-derived EVs in 7 severe COVID-19 patients, 2020.
-
EXO-CD24 (inhaled, Tel Aviv Sourasky Medical Center, Arber N, et al.) — Phase 1 in 30 severe patients. Widely publicized; the reported outcomes were not from a controlled comparison.
-
NCT05808400 — UC-MSC exosomes for chronic cough after COVID-19.
Diabetic Kidney Disease / Chronic Kidney Disease
-
NEPHSTROM (NCT02585622). Perico N, Remuzzi G, et al. Safety and preliminary efficacy of mesenchymal stromal cell (ORBCEL-M) therapy in diabetic kidney disease: a randomized clinical trial (NEPHSTROM). J Am Soc Nephrol. 2023;34(10):1733–1751. – Cohort 1: 16 adults with type 2 diabetes and progressive DKD; single IV infusion of 80×10⁶ anti-CD362–selected allogeneic bone marrow MSCs. Safe; median annual rate of eGFR decline significantly lower vs placebo, though measured GFR did not differ.
-
Cohort 2 results (160×10⁶ cells, 18-month follow-up) published 2026 in Kidney International Reports. Supports safety and tolerability; one SAE (transient AKI during intercurrent illness, resolved).
-
EU Horizon 2020 consortium, led by Mario Negri Institute, Bergamo. A phase 2b study is the recommended next step — i.e., efficacy is not established.
-
Nassar W, El-Ansary M, Sabry D, et al. Umbilical cord mesenchymal stem cells derived extracellular vesicles can safely ameliorate the progression of chronic kidney diseases. Biomater Res. 2016;20:21. doi:10.1186/s40824-016-0068-0 – Grade III–IV CKD; reported improvement in renal function. Still the most-cited EV trial in nephrology.
Type 1 Diabetes
-
ProTrans (NCT03406585). Carlsson PO, et al. Umbilical cord–derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase 1/2 randomised double-blind placebo-controlled trial. Diabetologia. 2023;66(8):1431–1441. doi:10.1007/s00125-023-05934-3 – Allogeneic Wharton's jelly–derived MSCs in adults 18–40 with T1D diagnosed <2 years prior. C-peptide declined 47% with placebo vs 10% with ProTrans (p<0.05); insulin requirements rose by a median 10 U/day on placebo and were unchanged with treatment. No treatment-related SAEs. Small; sponsor-funded (NextCell Pharma).
-
Hu J, et al. Long-term effects of the implantation of Wharton's jelly–derived mesenchymal stem cells from the umbilical cord for newly-onset type 1 diabetes mellitus. Endocr J.
-
Cai J, et al. Umbilical cord mesenchymal stromal cell with autologous bone marrow cell transplantation in established type 1 diabetes: a pilot randomized controlled open-label clinical study. Diabetes Care. 2016;39(1):149–157. (Combination protocol — partially outside criteria.)
-
Lu J, et al. One repeated transplantation of allogeneic umbilical cord mesenchymal stromal cells in type 1 diabetes: an open parallel controlled clinical study. Stem Cell Res Ther. 2021.
Systemic Lupus Erythematosus and Lupus Nephritis
-
Sun L, et al. Umbilical cord mesenchymal stem cell transplantation in severe and refractory systemic lupus erythematosus. Arthritis Rheum. 2010;62(8):2467–75. – Single-arm, 16 patients. First human data in autoimmune disease with UC-MSCs.
-
Wang D, et al. Umbilical cord mesenchymal stem cell transplantation in active and refractory systemic lupus erythematosus: a multicenter clinical study. Arthritis Res Ther. 2014;16(2):R79. (NCT01741857.) – 40 patients, four centers in China. Overall survival 92.5%. Major clinical response 32.5%, partial 27.5% at 12 months. Relapse after 6 months in several patients. Single-arm — no control group.
-
Deng D, et al. A randomised double-blind, placebo-controlled trial of allogeneic umbilical cord–derived mesenchymal stem cell for lupus nephritis. Ann Rheum Dis. 2017;76(8):1436–1439. – 18 patients with WHO class III/IV LN. Remission 75% (9/12) with hUC-MSC vs 83% (5/6) with placebo — no benefit demonstrated. This trial is the single most important citation to give a lupus patient considering MSC therapy, and it is frequently omitted from promotional material.
-
Wang D, et al. Safety and feasibility of UC-MSCs in treatment-refractory SLE nephritis (commentary/analysis). Arthritis Res Ther. 2014.
-
Zeng L, et al. Efficacy and safety of mesenchymal stem cell transplantation in autoimmune diseases (RA, SLE, IBD, MS, ankylosing spondylitis): a systematic review and meta-analysis of randomized controlled trials. Stem Cells Int. 2022;2022:9463314.
-
Nurudhin A, Werdiningsih Y, Sunarso I, et al. Umbilical cord mesenchymal stem cell–derived secretome as a potential treatment for systemic lupus erythematosus: a double-blind randomized controlled trial. Narra J. 2025;5(1):e1799. doi:10.52225/narra.v5i1.1799 – 29 female patients, moderate disease activity, weekly 1.5 cc IM injections vs saline for six weeks. Note: "secretome" is not the same as a purified exosome preparation.
Decompensated Liver Cirrhosis
-
Shi M, et al. Mesenchymal stem cell therapy in decompensated liver cirrhosis: a long-term follow-up analysis of the randomized controlled clinical trial. Hepatol Int. 2021;15(6):1431–1441. doi:10.1007/s12072-021-10199-2 – 219 patients with HBV-related decompensated cirrhosis (111 control, 108 UC-MSC), three UC-MSC infusions at 4-week intervals plus conventional treatment, followed 75 months. One of the largest and longest-followed allogeneic MSC datasets in any indication.
-
MSC-DLC-2 (NCT05224960) — prospective, double-blind, multicenter randomized trial, 140 patients, three IV doses vs placebo, China. Check for results.
-
Human umbilical cord blood–derived MSC transplantation for patients with decompensated liver cirrhosis. J Gastrointest Surg. 2023;27(4). Retrospective cohort with propensity score matching, 201 subjects.
-
NCT01728727 — hUC-MSC via hepatic artery for HBV-related cirrhosis, randomized Phase 1/2
Sensorineural Hearing Loss
-
Warnecke A, Prenzler N, Harre J, et al. First-in-human intracochlear application of human stromal cell–derived extracellular vesicles. J Extracell Vesicles. 2021;10:e12094.
-
B5. Wound Healing, Burns, and Chronic Ulcers
-
Johnson J, Law SQK, Shojaee M, Hall AS, et al. Double-blind, placebo-controlled trial of platelet-derived extracellular vesicles for wound healing, using LEAP (ligand-based exosome affinity purification) chromatography. J Extracell Vesicles. 2023. (Exopharm; single subcutaneous injection into an experimentally induced skin lesion.) – Notable as one of very few double-blind placebo-controlled EV trials in existence.
-
Aegle Therapeutics AGLE-102 — first EV company cleared by FDA to enter human trials (IND cleared May 11, 2018). Phase 1/2a in severe second-degree burns; AGLE-103 in development for epidermolysis bullosa. Search ClinicalTrials.gov for current status and any published results.
-
NCT05475418 — human adipose tissue–derived exosomes in hydrogel applied topically to wounds; completed single-arm pilot, Shanghai Ninth People's Hospital.
-
First pilot case-control interventional study using autologous extracellular vesicles to treat chronic venous ulcers unresponsive to conventional treatment. Pharmacol Res. 2023;190:106718.
PART B — PEPTIDES
Selank and Semax are two synthetic neuropeptides developed at the Institute of Molecular Genetics of the Russian Academy of Sciences. Both are given intranasally, both are approved prescription drugs in Russia, and both have been used for decades to treat brain recovery and anxiety with decades of human trials performed outside of the U.S. Semax has been approved outside of the US since the 1990s and Selank since 2009, both as prescription medicines.
-
Semax in Alzheimers:
-
Radchenko AI, Kuzubova EV, Apostol AA, Mitkevich VA, Andreeva LA, Limborska SA, Stepenko YV, Shmigerova VS, Solin AV, Korokin MV, Pokrovskii MV, Myasoedov NF, Makarov AA. The Potential of the Peptide Drug Semax and Its Derivative for Correcting Pathological Impairments in the Animal Model of Alzheimer's Disease. Acta Naturae. 2025 Oct-Dec;17(4):110-120. doi: 10.32607/actanaturae.27808. PMID: 41479572; PMCID: PMC1275587
-
-
Semax in Neurodegenerative Disorders:
-
Giri S, Chandra P. Modulation of neuropathological pathways by bioactive peptides and proteins/polypeptides: Targeting oxidative stress in neurodegenerative diseases. Neuropeptides. 2025 Dec;114:102563. doi: 10.1016/j.npep.2025.102563. Epub 2025 Sep 21. PMID: 41004910.
-
Semax in Stroke and Spinal Cord Injury:
-
Liu R, Chen Y, Huang H, Li X, Lv J, Jiang L, Jiang H, Wu C, Chen W, Xu H, Zhu Z, Cai H, Xiao J, Yin L, Ni W. Semax peptide targets the μ opioid receptor gene Oprm1 to promote deubiquitination and functional recovery after spinal cord injury in female mice. Br J Pharmacol. 2025 Nov;182(22):5489-5516. doi: 10.1111/bph.70122. Epub 2025 Jul 21. PMID: 40692165.
-
Gusev EI, et al. Clinical studies of Semax in neurological disorders.
-
-
Semax in Stroke
-
Semax and Pro-Gly-Pro Activate the Transcription of Neurotrophins and Their Receptor Genes after Cerebral Ischemia
-
Filippenkov IB, Shpetko YY, Ales DA, Stavchansky VV, Denisova AE, Yuzhakov VV, Fomina NK, Gubsky LV, Andreeva LA, Myasoedov NF, Limborska SA, Dergunova LV. Genes That Associated with Action of ACTH-like Peptides with Neuroprotective Potential in Rat Brain Regions with Different Degrees of Ischemic Damage. Int J Mol Sci. 2025 Jun 28;26(13):6256. doi: 10.3390/ijms26136256. PMID: 40650034; PMCID: PMC12249733.
-
Asadullah A, Bajamal AH, Parenrengi MA, Turchan A, Utomo B, Sudiana IK, Subagio EA. Effect of ACTH4-10Pro8-Gly9-Pro10 on anti-inflammatory cytokine (IL-4, IL-10, IL-13) expression in acute spinal cord injury models (male Sprague Dawley rats). F1000Res. 2025 Sep 22;12:194. doi: 10.12688/f1000research.127413.2. PMID: 41179234; PMCID: PMC12579320.
-
-
Selank in Anxiety: Selank: head-to-head trials against benzodiazepines (for example Zozulya and colleagues, ~62 patients, versus medazepam; and a phenazepam comparison of ~60 patients) reported anxiolytic effects comparable to those drugs but without sedation or dependence. Across the Russian trials, roughly 190 patients have been studied with very few adverse effects reported.
-
In trials selank's anti-anxiety effect was described as comparable to benzodiazepines such as medazepam and phenazepam, but reportedly without the sedation, cognitive impairment, or dependence associated with that drug class.
-
Inozemtseva LS, Yatsenko KA, Glazova NY, Kamensky AA, Myasoedov NF, Levitskaya NG, Grivennikov IA, Dolotov OV. Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress. Eur J Pharmacol. 2024 Dec 5;984:177068. doi: 10.1016/j.ejphar.2024.177068. Epub 2024 Oct 21. PMID: 39442746.
-
Kasian A, Kolomin T, Andreeva L, Bondarenko E, Myasoedov N, Slominsky P, Shadrina M. Peptide Selank Enhances the Effect of Diazepam in Reducing Anxiety in Unpredictable Chronic Mild Stress Conditions in Rats. Behav Neurol. 2017;2017:5091027. doi: 10.1155/2017/5091027. Epub 2017 Feb 9. PMID: 28280289; PMCID: PMC5322660.
-
Ashmarin IP, et al. Clinical studies of Selank in anxiety and cognitive disorders.
-
GLOW Peptide Stack Results
-
The timeline below reflects patterns people describe, not guaranteed outcomes. Reported effects develop gradually because the underlying processes — gene expression, collagen turnover, tissue remodeling — unfold over weeks.
-
-
What people commonly describe
-
Week 1
-
Little visible change; some report subtle shifts in sleep or recovery. Early dramatic effects often reflect expectation.
-
Weeks 2–3
-
First tangible changes for some — skin feeling softer or more hydrated; reduced soreness in those using it for recovery.
-
Weeks 4–6
-
More noticeable skin and recovery changes reported by responders.
-
Weeks 7–12
-
Reported peak effects for those who continue; results vary considerably between individuals.
-
-
Factors that influence individual response include age, baseline skin or tissue condition, consistency of use, and lifestyle factors such as sleep, nutrition, sun exposure, and smoking.
-
Reported side effects are usually described as mild and temporary, but the absence of large safety studies means the full risk picture is not known.
-
Injection-site reactions: redness, itching, or mild swelling are the most commonly reported complaints.
-
Fatigue or headache: some users report tiredness or mild headache, particularly early on.
-
Nausea or flushing: less commonly reported; flushing is sometimes attributed to the copper in GHK-Cu.
Hair Loss
-
MICRONEEDLING WITH AHK-CU WEEKLY X 5 SESSION MONTHLY SHOWED 26.5% IMPROVEMENT
-
https://hairgenetix.com/blogs/articles/copper-peptide-microneedling-hair-regrowth-2025-study?srsltid=AfmBOoq-C8pp8AYj50Avta5xcmGWxu1fo6f9tL5dQJJf5CcmnmJIKR0C
-
KA combination treatment of minoxidil, dutasteride, and copper peptides delivered via "tattooing" microneedling produced a median 26.5% hair regrowth across 5 monthly sessions (p < 0.001). The SALT score (a measure of hair loss severity) dropped from a median of 40% to 7.5% — a dramatic improvement. 71.4% of patients (5 out of 7) achieved more than 10% scalp area regrowth. The 5-session protocol was significantly more effective than the previous 3-session protocol (26.5% vs 10%, p = 0.0025). Zero adverse events were reported — no scarring, infection, or complications. These patients had all failed at least 1 year of standard treatment before starting this protocol.
-
PART C — WHERE CAN I FIND MORE INFO?
-
PubMed / National Library of Medicine — for primary research on each peptide
-
The Cleveland Clinic, Peptides for Skin Care: Are They Worth It?, July 2024
-
National Library of Science, Regenerative and Protective Actions of the GHK-Cu Peptide in the Light of the New Gene Data, Pickart, L., Margolina, A., July 2018
-
National Library of Science, Taking a gamble or playing by the rules: dissociable prefrontal systems implicated in probabilistic versus deterministic rule-based decisions, Bhanji, J.P., Beer, J.S., Bunge, S.A., September 2009
-
National Library of Science, Utilizing Developmentally Essential Secreted Peptides Such as Thymosin Beta-4 to Remind the Adult Organs of Their Embryonic State—New Directions in Anti-Aging Regenerative Therapies, Maar, K., Hetenyi, R., Maar, S., Faskerti, G., Hanna, D., Lippai, B., Takatsy, A., Bock-Marquette, I, May 2021
-
Healthline, How Copper Peptides Assist the Health of Your Skin and Hair, Perkins, S., M.D., October 2020
-
National Library of Science, Impact of Collagen Peptide Supplementation in Combination with Long-Term Physical Training on Strength, Musculotendinous Remodeling, Functional Recovery, and Body Composition in Healthy Adults: A Systematic Review with Meta-analysis, Bischof, K., Moitzi, A.M., Stafilidis, S., König, D., July 2024
-
U.S. FDA Consumer Updates — for regulatory status and safety communications
PART D — WEBSITE CONTENT SUPPORT
-
Trends in Multiple Chronic Conditions Among US Adults, by Life Stage — CDC, Preventing Chronic Disease, 2025 — 59.5% of adults 18–34 have ≥1 chronic condition (2023), up from 52.5% in 2013; 27.1% have two or more.
-
Prevalence of metabolic syndrome in the United States, NHANES 2011–18 — Postgraduate Medical Journal — 22.2% of adults aged 20–39 meet metabolic syndrome criteria.
-
Prevalence of Selected Chronic Conditions Among Adults Age 45 and Older — CDC/NCHS, 2024 — background reference.
