Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis Shoulder
Conditions
Keywords
Autologous Adipose-derived Stem Cells (AdMSCs)
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).
Interventions
BIOLOGICALCelltex- AdMSCs
Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Sponsors
Celltex Therapeutics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and evaluators
Intervention model description
The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Any organ damage or safety concerns determined by SMAC 20 blood test. | 12 months | Safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| changes in joint images (X-ray or MRI) from the baseline | 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline | 12 months | efficacy |
| Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline | 12 months | efficacy |
Countries
United States
Contacts
Primary ContactJane Young
Outcome results
None listed