Mesenchymal Stem/Stromal Cell Therapy in the Treatment of Frailty

NCT04919135 | Completed Phase 1

• 1 other identifier: VinmecISC2111
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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

Conditions

Frailty

Keywords

Frailty; umbilical cord mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• Adverse events and serious adverse events

  To assess safety, the number of AEs or SAEs during stem cell administration (72 h) at 1 months, 3 months, 6 months and 9 months after discharge will be evaluated

  up to the 9-month period following treatment

Secondary Outcomes (11)

• Reduced activities

  up to the 9-month period following treatment

• Slowing of mobility

  up to the 9-month period following treatment

• reduction of handgrip strength

  up to the 9-month period following treatment

• exhaustion

  up to the 9-month period following treatment

• the level of pain in the knee

  up to the 9-month period following treatment

Study Arms (2)

Treatment (UC-MSC trasnplatation)

EXPERIMENTAL

1.5 x 10\^6 umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 3 months after the first transplantation and combination with standard frailty treatment and supplementary medication

Biological: Umbilical Cord Mesenchymal Stem Cells transplantation; Drug: standard frailty treatment and supplementary medication

control arm

OTHER

standard frailty treatment and supplementary medication

Drug: standard frailty treatment and supplementary medication

Interventions

Umbilical Cord Mesenchymal Stem Cells transplantation BIOLOGICAL

Patients assigned to UC-MSC administration groups will receive two administrations at a dose of 1.5 million cells/kg patient body weight via the IV route with a 3-month intervening interval

Treatment (UC-MSC trasnplatation)

standard frailty treatment and supplementary medication DRUG

Hightamine (Hankook Korus Pharm, Korea), Total calcium (Nugale Pharmaceutical, Canada), Bioflex (Ausbiomed, Australia)

Treatment (UC-MSC trasnplatation); control arm

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must show signs of frailty apart from a concomitant condition as assessed by the investigator with a frailty score \>=3 using the Fried Phenotype Scale.
• They showed the signs of frailty based on physician assessment, apart from a concomitant condition, by a score between 3 and 6 as denoted by the Canadian Study on Health Aging.
• Must provide written informed consent.

You may not qualify if:

• Score of less than or equal to 20 on the Mini-Mental State Examination (MMSE)
• Active listing (or expected future listing) for transplant of any organ.
• Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin \<8 g/dl, white blood cell count \<3000/mm3, platelets\<80,000/mm3, alkaline phosphatase \> 3 times the upper limit of normal, total bilirubin \> 1.5 mg/dl.
• Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to HIV, advanced liver or renal failure, class II/III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilator defect, COPD with GOLD D, ischemic stroke with NIHSS \<5, type II diabetes with HbA1C \>8.5%
• Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
• Be an organ transplant recipient.
• Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease-free for 5 years), except curatively treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma if recurrence occurs.
• Have a non-pulmonary condition that limits lifespan to \< 1 year.

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Hanoi, 100000, Vietnam

Location

Related Publications (4)

• Tompkins BA, DiFede DL, Khan A, Landin AM, Schulman IH, Pujol MV, Heldman AW, Miki R, Goldschmidt-Clermont PJ, Goldstein BJ, Mushtaq M, Levis-Dusseau S, Byrnes JJ, Lowery M, Natsumeda M, Delgado C, Saltzman R, Vidro-Casiano M, Da Fonseca M, Golpanian S, Premer C, Medina A, Valasaki K, Florea V, Anderson E, El-Khorazaty J, Mendizabal A, Green G, Oliva AA, Hare JM. Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1513-1522. doi: 10.1093/gerona/glx137.

  PMID: 28977399 BACKGROUND

• Golpanian S, DiFede DL, Pujol MV, Lowery MH, Levis-Dusseau S, Goldstein BJ, Schulman IH, Longsomboon B, Wolf A, Khan A, Heldman AW, Goldschmidt-Clermont PJ, Hare JM. Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty. Oncotarget. 2016 Mar 15;7(11):11899-912. doi: 10.18632/oncotarget.7727.

  PMID: 26933813 BACKGROUND

• Hoang VT, Le DS, Hoang DM, Phan TTK, Ngo LAT, Nguyen TK, Bui VA, Nguyen Thanh L. Impact of tissue factor expression and administration routes on thrombosis development induced by mesenchymal stem/stromal cell infusions: re-evaluating the dogma. Stem Cell Res Ther. 2024 Feb 27;15(1):56. doi: 10.1186/s13287-023-03582-3.

  PMID: 38414067 DERIVED

• Hoang DM, Nguyen KT, Hoang VT, Dao LTM, Bui HT, Ho TTK, Nguyen TTP, Ngo ATL, Nguyen HK, Thanh LN. Clinical Study of Mesenchymal Stem/Stromal Cell Therapy for the Treatment of Frailty: A Proposed Experimental Design for Therapeutic and Mechanistic Investigation. J Gerontol A Biol Sci Med Sci. 2022 Jul 5;77(7):1287-1291. doi: 10.1093/gerona/glab326.

  PMID: 34718548 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liem Thanh Thanh, Prof

  Vinmec Research Institute of Stem Cell and Gene Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 9, 2021
• Study Start: October 19, 2021
• Primary Completion: April 20, 2023
• Study Completion: December 30, 2024
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)