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NCT04919135
Mesenchymal Stem/Stromal Cell Therapy in the Treatment of Frailty
Completed
Phase 1, PHASE2
Last updated 17 August 2025
What this trial tests
Phase 1, PHASE2 trial testing Umbilical Cord Mesenchymal Stem Cells transplantation in Frailty in 158 participants. Completed in 30 December 2024.
Timeline
19 October 2021
Primary endpoint
20 April 2023
20 April 2023
30 December 2024
Quick facts
| Lead sponsor | Vinmec Research Institute of Stem Cell and Gene Technology |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 158 |
| Start date | 19 October 2021 |
| Primary completion | 20 April 2023 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across Vietnam |
Drugs / interventions tested
- Umbilical Cord Mesenchymal Stem Cells transplantation — full drug profile →
- standard frailty treatment and supplementary medication — full drug profile →
Conditions studied
- Frailty — all drugs for Frailty →
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
Who can join
Adults 60 to 85, any sex, with Frailty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) in combination with standard frailty treatment in Vietnam
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic Mesenchymal Stem/Stromal Cells: Value, Challenges and Optimization.
Najar M, Melki R, Khalife F, Lagneaux L, et al · · 2021 · cited 64× · PMID 35096805 · DOI 10.3389/fcell.2021.716853 -
Looking at frailty and intrinsic capacity through a geroscience lens: the ICFSR & Geroscience Task Force.
de Souto Barreto P, Rolland Y, Ferrucci L, Arai H, et al · · 2023 · cited 21× · PMID 37985720 · DOI 10.1038/s43587-023-00531-w -
Impact of tissue factor expression and administration routes on thrombosis development induced by mesenchymal stem/stromal cell infusions: re-evaluating the dogma.
Hoang VT, Le DS, Hoang DM, Phan TTK, et al · · 2024 · cited 16× · PMID 38414067 · DOI 10.1186/s13287-023-03582-3 -
Recent clinical trials with stem cells to slow or reverse normal aging processes.
Garay RP. · · 2023 · cited 14× · PMID 37090485 · DOI 10.3389/fragi.2023.1148926 -
Clinical Study of Mesenchymal Stem/Stromal Cell Therapy for the Treatment of Frailty: A Proposed Experimental Design for Therapeutic and Mechanistic Investigation.
Hoang DM, Nguyen KT, Hoang VT, Dao LTM, et al · · 2022 · cited 3× · PMID 34718548 · DOI 10.1093/gerona/glab326 -
Safety and efficacy of allogeneic umbilical cord-derived mesenchymal stem cell infusion for frailty: a phase 2, single-centre, randomised, open-label controlled trial.
Nguyen LT, Nguyen KT, Dao LTM, Hoang VT, et al · · 2026 · PMID 42019090 · DOI 10.1016/j.ebiom.2026.106268
Verify or expand the search:
- PubMed search for NCT04919135
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Umbilical Cord Mesenchymal Stem Cells transplantation
Trials testing the same drug.
- NCT04433104 — Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Chronic Obstructive Pulmonary Disease · Phase 1, PHASE2 · completed
Other recruiting trials for Frailty
Currently open trials in the same condition.
- NCT07481188 — Frailty and Nottingham Hip Fracture Score for Predicting 90-Day Mortality After Hip Fracture Surgery · recruiting
- NCT07519603 — Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program · NA · recruiting
- NCT07144527 — Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults · NA · recruiting
- NCT07392944 — Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Home · NA · recruiting
- NCT07475767 — Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit · recruiting
Other Vinmec Research Institute of Stem Cell and Gene Technology trials
Trials by the same sponsor.
- NCT07472270 — Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment · Phase 1 · not yet recruiting
- NCT06629324 — Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia · Phase 2 · recruiting
- NCT06726538 — Investigating the Efficacy of Autologous, Adipose-derived Mesenchymal Stem Cell Therapy for the Treatment of Sexual Func · Phase 1, PHASE2 · completed
- NCT06027957 — CD19 CAR T-Cell Therapy for R/R Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia · Phase 1 · completed
- NCT05329662 — Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04919135 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vinmec Research Institute of Stem Cell and Gene Technology
- Last refreshed: 17 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04919135.
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