Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
Phase 2
Not yet recruiting
- Conditions
- Osteoarthritis, HipOsteoarthritis ShoulderOsteoarthritis, Knee
- Interventions
- Biological: Celltex- AdMSCs
- Registration Number
- NCT04448106
- Lead Sponsor
- Celltex Therapeutics Corporation
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 2 Arm 5 - OA Shoulder Celltex- AdMSCs 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. Phase 2 Arm 1 - OA Knee Celltex- AdMSCs 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. Phase 2 Arm 2 OA Knee Celltex- AdMSCs 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 Phase 2 Arm 3 - OA Hip Celltex- AdMSCs 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. Phase 2 Arm 4 - OA Hip Celltex- AdMSCs 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 Phase 2 Arm 6 - OA Shoulder Celltex- AdMSCs 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
- Primary Outcome Measures
Name Time Method Any organ damage or safety concerns determined by SMAC 20 blood test. 12 months Safety
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. 12 months safety
- Secondary Outcome Measures
Name Time Method 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 efficacy
Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients 12 months efficacy
Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients 12 months efficacy
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 efficacy
changes in joint images (X-ray or MRI) from the baseline 12 months efficacy
Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients 12 months efficacy
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 efficacy
Trial Locations
- Locations (1)
Stanley C Jones
🇺🇸Houston, Texas, United States