Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT04919135
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2021-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem/Stromal Cell Therapy in the Treatment of Frailty
Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Organization:
Study Overview
Official Title:
Clinical Study of Mesenchymal Stem/Stromal Cell Therapy in Frailty: a Proposed Experimental Design for Therapeutic and Mechanism Investigation
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Frailty, a specific condition of increased vulnerability and reduced general health associated with aging in elderly people, is an emerging global burden requiring major implications for clinical practice and public health. The lack of standardized definition and treatment of the disease resulted in the increasing number of elders diagnosed with frailty. Recently, preclinical and clinical studies support the safety of mesenchymal stem/stromal cells (MSCs) in the treatment of frailty. However, no comprehensive study has been conducted to access the interrelationship between frailty conditions and the effects of MSC-based therapy. To fill this knowledge gap, the aim of the 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. Moreover, this study describes the rationale, study design, methodologies, and analysis strategy currently employed in stem cell research and clinical study. This randomized case-control phase I/II trial is conducted at Vinmec Times City International Hospital, Hanoi, Vietnam between July 2021 and November 2022. In this trial, 44 patients will be enrolled and randomized into a UC-MSC administration group and control group. Both groups will receive the standard frailty treatment and supplementary medication. The UC-MSC group will receive two doses of thawed UC-MSC product at 1.5x10\^6 cells/kg of patient body's weight with an intervention interval of three months. The primary outcome measures will include the incidence of prespecified administration-associated adverse events (AEs) and serious adverse events (SAEs). The potential efficacy will be evaluated based on the improvement in frailty conditions (including physical examination, patient-reported outcomes, quality of life, immune markers of frailty, metabolism analysis, and cytokine markers from patient's plasma). The clinical evaluation will be conducted at baseline and 1-, 3-, 6- and 9-months post-intervention. This clinical trial and stem cell analysis associated with patients' sampling at different timepoints seeks to identify and characterize the potential effects of UC-MSCs on the improvement of frailty based on stem cell quality, cytokines/growth factors secretion profiles of UC-MSCs, cellular senescence, and metabolic analysis of patient's CD3+ cells. The ultimate results of the study will be essential for evaluating the utility of UC-MSC therapy for the treatment of frailty and mechanism underlying these effects providing the fundamental knowledge for designing and implementing research strategy of future studies
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: