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

NCT04170426 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-04-18

No results posted yet for this study

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

Interventions

BIOLOGICAL

autologous adipose derived stem cells

Culture expanded mesenchymal stem cells isolated from patient's own abdominal fat tissue

Sponsors & Collaborators

  • Celltex Therapeutics Corporation

    lead INDUSTRY

Principal Investigators

  • Derek W Guillory, MD · Root Causes Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-12-31
Completion
2026-12-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04170426 on ClinicalTrials.gov