A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty - Trial NCT06070532
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.
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Study Focus
Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
Interventional
biological
Sponsor & Location
Cellcolabs Clinical LTD.
Timeline & Enrollment
Phase 1/2
Oct 09, 2023
Jan 10, 2025
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
Data Source
ClinicalTrials.gov
NCT06070532
Non-Device Trial