Osteoarthritis, Knee Clinical Trial
— AdMSCsOfficial title:
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).
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | August 15, 2026 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanley C Jones | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Celltex Therapeutics Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline | efficacy | 12 months | |
Other | Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline | efficacy | 12 months | |
Primary | 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 | |
Primary | Any organ damage or safety concerns determined by SMAC 20 blood test. | Safety | 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | changes in joint images (X-ray or MRI) from the baseline | efficacy | 12 months |
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