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NCT06087848Recruiting

A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events

A Longitudinal Open-Label Multi-center Single-Arm Phase I/IIa Study to Evaluate the Safety and Preventive Effect on Cardiovascular Events of Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product, StromaForte, in Study Participants.
Cellcolabs Clinical LTD.Phase 1/2ClinicalTrials.govbiological
Study focus
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 07, 2023
End date
Jul 06, 2024
Enrollment
30 participants
Primary outcome

To evaluate the number of adverse events or severe adverse event assessed by Common Terminology Criteria For Adverse Events (CTCAE) of intravenous infusion of human allogeneic BM-derived MSCs product StromaForte for all study participants.

Summary

The goal of this phase I/II clinical trial is to evaluate the safety and preventive effect of
 intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product
 StromaForte in study participants. 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) To evaluate
 the effects of Mesenchymal stem cells on Prevention of Cardiovascular Events by following the
 reported incidence of cardiovascular events amongst study participants up to five year
 post-injection 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
Cardiovascular disease, unspecifiedHypertensive heart diseaseOther ill-defined heart diseasesHeart disease, unspecifiedObservation for other suspected cardiovascular diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06087848
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06087848 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 Cardiovascular Diseases. Target enrollment is 30 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.