drugset / Trial / NCT04448106

Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis

NCT04448106 ↗

Phase 2 Not yet recruiting 300 enrolled Celltex Therapeutics Corporation
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).

Timeline

Start
2023-09-25
Primary completion
2024-08-01
Completion
2026-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Celltex- AdMSCs Cell therapy 1e+06 cells/kg Intravenous
Subject Celltex- AdMSCs Cell therapy 2e+06 cells/kg Intravenous
Subject Celltex- AdMSCs Cell therapy 2.86e+06 cells/kg Intravenous