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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
|
| 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. |
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| 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 |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celltex- AdMSCs | Biological | Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Young | Contact | 7135901000 | jyoung@celltexbank.com |
| Name | Affiliation | Role |
|---|---|---|
| Derek W Guillory, MD. | Root Causes Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanley C Jones | Houston | Texas | 77098 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.
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Patients and evaluators
|
| 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 |
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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 |
efficacy
| 12 months |
| D012216 |
| Rheumatic Diseases |