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NCT06070532

A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty

A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy, Phase I/IIa Clinical Study of Cellcolabs' Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty
Cellcolabs Clinical LTD.·Phase 1/2·ClinicalTrials.gov·biologicalRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Frailty
Drug/Device/Intervention
Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Cellcolabs Clinical LTD.
Location
Nassau, Bahamas
Timeline & enrollment
Phase
Phase 1/2
Start date
Oct 09, 2023
End date
Jan 10, 2025
Enrollment
12 participants
Primary outcome

To evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product Stromaforte

Summary

The goal of this phase I/II clinical trial is to evaluate the safety and tolerability of
 intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product
 StromaForte in patients with aging frailty. The main questions it aims to answer are:
 
 To assess the safety and tolerability after 28 days of injection by reporting the number of
 adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE)
 
 Observe the change in inflammatory markers from baseline to 6 months (baseline to 28, 84, and
 168 days post-infusion.)
 
 Participants will receive 100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal
 Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given
 via slow intravenous infusion 100 million cells in approximately 30 min

ICD-10 classifications
Unattended deathIndividuals with autosomal fragile site
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06070532
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06070532 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Cellcolabs Clinical LTD. and is currently Recruiting. The study focuses on Frailty. Target enrollment is 12 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.