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

Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis Shoulder
• Intervention / Treatment: Biological: Celltex- AdMSCs

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jane Young; Phone Number: 7135901000; Email: jyoung@celltexbank.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77098
      • Stanley C Jones
      • Contact: Sally McGahee, BS; Phone Number: 147 713-590-1000; Email: smcgahee@celltexbank.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2 Arm 1 - OA Knee; 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; Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue; Other Names: AdMSCs
Active Comparator: Phase 2 Arm 2 OA Knee; 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; Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue; Other Names: AdMSCs
Experimental: Phase 2 Arm 3 - OA Hip; 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; Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue; Other Names: AdMSCs
Active Comparator: Phase 2 Arm 4 - OA Hip; 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; Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue; Other Names: AdMSCs
Experimental: Phase 2 Arm 5 - OA Shoulder; 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; Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue; Other Names: AdMSCs
Active Comparator: Phase 2 Arm 6 - OA Shoulder; 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; Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue; Other Names: AdMSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	efficacy	12 months
Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients	efficacy	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	efficacy	12 months
Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients	efficacy	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	efficacy	12 month
Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients	efficacy	12 months
changes in joint images (X-ray or MRI) from the baseline	efficacy	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline	efficacy	12 months
Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline	efficacy	12 months

Collaborators and Investigators

• Sponsor: Celltex Therapeutics Corporation
• Investigators: Principal Investigator: Derek W Guillory, MD., Root Causes Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): September 25, 2023
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 15, 2026

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Autologous Adipose-derived Stem Cells (AdMSCs)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: CTX0020-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No