NCT04448106

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

Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Celltex Therapeutics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Osteoarthritis, Knee
• Osteoarthritis, Hip
• Osteoarthritis Shoulder

Interventions

Type	Name	Description
BIOLOGICAL	Celltex- AdMSCs	Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Timeline

• Start date: 2023-09-25
• Primary completion: 2024-08-01
• Completion: 2026-08-15
• First posted: 2020-06-25
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study