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COMPLETED
NCT06063590
PHASE1/PHASE2

A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients

Sponsor: Cellcolabs Clinical SPV Limited

View on ClinicalTrials.gov

Summary

This phase I/IIa study in frail patients is designed to assess the safety of intravenous human allogenic bone marrow-derived mesenchymal stromal cell product StromaForte by reporting the number of adverse events assessed by Common Terminology Criteria. 12 male and female patients aged 60 to 85 years will be enrolled.

Official title: An Open-Label Single-Arm Phase I/IIa Study to Evaluate the Safety of Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte in Patients With Aging Frailty

Key Details

Gender

All

Age Range

60 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-01-22

Completion Date

2025-08-28

Last Updated

2026-04-16

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

StromaForte

100 millions 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 in approximately 30 min

Locations (1)

Burjeel Medical City

Abu Dhabi, United Arab Emirates