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Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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)

NCT04170426•Celltex Therapeutics Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must pass communicable disease screen tests for HIV, syphilis, Hepatitis B and C Consistent with American Rheumatism Association-European League Against Rheumatism (ACR/EULAR) 2010 rheumatoid arthritis classification criteria
•Active Rheumatoid Arthritis, see RA functional status of class I-IV
•Patients must meet at least one of the following: \> 6 swollen joints and ≥ 6 involved joints (tenderness, swelling, deformity, pain on motion, or decreased motion) and morning stiffness ≥ 45 minutes based on 68 joint count.
•Patients must also meet at least one of the following: rheumatoid factor (RF) \> 15 IU/mL or \> 1:16, C-reactive protein (CRP) \> 2.0 mg/dL, Erythrocyte Sedimentation Rate (ESR) \> 30 mm/hour, and anti-cyclic citrullinated protein (Anti-CCP) \> 20 U/mL, TNFα \> 2.8 pg/mL.
•Patients must have failed anti-rheumatoid drug due to adverse event or inefficacy for at least 12 week and at least 4 weeks on stable dose of methotrexate ≤ 25 mg/week, or leflunomide ≤ 20 mg/day, or sulfasalazine ≤ 3 g/day, or steroids (Prednisone \<10 mg/day).
•For other medications, patients must be on the stable dose for at least 4 weeks prior to study entry in order to preclude changes to patient medication while participating on the study to ensure that a medication change could become a confounding factor in data interpretation.
•All patients must be clinically stable with no significant changes in health status a minimum of at least 4 weeks prior to randomization and confirming patient eligibility

Exclusion Criteria

•1. Current or prior to treatment
•* Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
•* Evidence of immune suppression related to prior/current therapy
•* \> 10% change in delivered monthly dose of anti-rheumatoid medications within 4 weeks prior to this stem cell infusion
•* Use of a new or additional anti-rheumatoid medication within 6 weeks prior to this stem cell infusion
•* Use of other stem cell therapy within 12 weeks prior to this stem cell therapy
•* Unwillingness or inability to comply with study procedures
•2. Concurrent Conditions
•* Clinically active malignant disease
•* Severe bladder or thrombotic disorder
+17 more criteria

Key Dates

Start Date

December 1, 2023

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2026

Last Updated

April 18, 2023

Enrollment

ESTIMATED participants

Conditions

Rheumatoid Arthritis

Interventions

autologous adipose derived stem cells

BIOLOGICAL

Contacts

Jane Young

CONTACT

7135901000 jyoung@celltexbank.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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