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

NCT04448106 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: CTX0020-002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Autologous Adipose-derived Stem Cells (AdMSCs)

Outcome Measures

Primary Outcomes (2)

• the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.

  safety

  12 months

• Any organ damage or safety concerns determined by SMAC 20 blood test.

  Safety

  12 months

Secondary Outcomes (7)

• Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients

  12 months

• Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients

  12 months

• Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients

  12 months

• Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients

  12 months

• Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients

  12 month

Other Outcomes (2)

• Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline

  12 months

• Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline

  12 months

Study Arms (6)

Phase 2 Arm 1 - OA Knee

EXPERIMENTAL

50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.

Biological: Celltex- AdMSCs

Phase 2 Arm 2 OA Knee

ACTIVE COMPARATOR

Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

Biological: Celltex- AdMSCs

Phase 2 Arm 3 - OA Hip

EXPERIMENTAL

50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.

Biological: Celltex- AdMSCs

Phase 2 Arm 4 - OA Hip

ACTIVE COMPARATOR

Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

Biological: Celltex- AdMSCs

Phase 2 Arm 5 - OA Shoulder

EXPERIMENTAL

50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.

Biological: Celltex- AdMSCs

Phase 2 Arm 6 - OA Shoulder

ACTIVE COMPARATOR

Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

Biological: Celltex- AdMSCs

Interventions

Celltex- AdMSCs BIOLOGICAL

Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Also known as: AdMSCs

Phase 2 Arm 1 - OA Knee; Phase 2 Arm 2 OA Knee; Phase 2 Arm 3 - OA Hip; Phase 2 Arm 4 - OA Hip; Phase 2 Arm 5 - OA Shoulder; Phase 2 Arm 6 - OA Shoulder

Eligibility Criteria

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

You may qualify if:

• Age above 18 years
• Male or female
• Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage)
• Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
• Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.

You may not qualify if:

• Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
• Unwillingness or inability to comply with study procedures
• Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
• Clinically active malignant disease
• Previous thrombotic disorder
• History of known pulmonary embolism or known secondary anti-phospholipid syndrome
• Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)
• Major trauma or surgery within 14 days of study treatment start
• Mental condition rendering the subject (or the subject's legally acceptable representative\[s\]) unable to understand the nature, scope and possible consequences of the study
• Alcohol, drug, or medication abuse within one year prior to study treatment start
• Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
• Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
• Patients or family history with a hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
• History of long-term use of immunosuppressive agents
• Organ transplants in the previous 6 months

Sponsors & Collaborators

• Celltex Therapeutics Corporation: lead

Study Sites (1)

Stanley C Jones

Houston, Texas, 77098, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and evaluators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: September 25, 2023
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (1)