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

NCT04170426 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CTX0019-001
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Adverse Events and Sever Adverse Events

  The total number of adverse events and severe adverse events related and non-related with AdMSCs will be recorded to indicate the safety and tolerability.

  52 weeks

Secondary Outcomes (1)

• Efficacy of Celltex AdMSCs

  52 weeks

Study Arms (3)

Phase 1 ARM 0

EXPERIMENTAL

9 subjects receive dose escalation of autologous AdMSCs via Intravenous infusion in Phase 1

Biological: autologous adipose derived stem cells

Phase 2 ARM 1

ACTIVE COMPARATOR

30 subjects receive three doses of 2.0-2.86×10\^6 cells/kg on day 1, 4 and 7 via Intravenous infusion in Phase 2a

Biological: autologous adipose derived stem cells

Phase 2 ARM 2

PLACEBO COMPARATOR

15 subjects receive three doses of placebo on day 1, 4 and 7 via Intravenous infusion in Phase 2a

Biological: autologous adipose derived stem cells

Interventions

autologous adipose derived stem cells BIOLOGICAL

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

Also known as: Celltex-AdMSCs

Phase 1 ARM 0; Phase 2 ARM 1; Phase 2 ARM 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Concurrent Conditions
• Clinically active malignant disease
• Severe bladder or thrombotic disorder
• History of known pulmonary embolism or known secondary anti-phospholipid syndrome
• Known or suspected hypersensitivity to any components used to culture or store the AdMSCs, e.g. sulfur or sulfonamide
• Known or suspected antibodies to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO)
• Active infection at time of planned study treatment start
• Age related pathology likely to inhibit study participation or completion

Sponsors & Collaborators

• Celltex Therapeutics Corporation: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Derek W Guillory, MD

  Root Causes Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Young

CONTACT

7135901000; jyoung@celltexbank.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Combined Phase 1 dose escalation study and Phase 2a randomized, placebo controlled and double blinded study using autologous adipose stem cells (Celltex AdMSCs) for rheumatoid arthritis patients who failed disease-modifying antirheumatic drug (DMARDs).

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share