NCT04170426

Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis

Phase 1/2a Clinical Study for Subjects With Rheumatoid Arthritis (RA) Using Multiple Dose Intravenous Infusions of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Celltex Therapeutics Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an investigational new drug clinical trial for combined Phase 1 dose escalation study and Phase 2a randomized, placebo controlled and double blinded study using intravenous injection of autologous adipose stem cells (Celltex AdMSCs) for rheumatoid arthritis patients. All subjects are monitored for safety (adverse events/severe adverse events) and evaluated for RAPID3, DAS28 and ACR20 regarding AdMSCs up to 52 weeks study duration.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	autologous adipose derived stem cells	Culture expanded mesenchymal stem cells isolated from patient's own abdominal fat tissue

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2026-12-01
• First posted: 2019-11-20
• Last updated: 2023-04-18

Regulatory

• FDA-regulated drug study