Osteoarthritis Knee
Conditions
Brief summary
The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.
Interventions
Sponsors
Steminent Biotherapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray. 2. Subject's pain score is 8-13 points (Lequesne's index). 3. Ages between 50-70 years. 4. Signed informed consent from the subject. 5. Female subjects should be post-menopausal women
Exclusion criteria
1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV. 2. Subject not suitable for liposuction surgery. 3. Subject with hypersensitivity/allergy to anesthetic. 4. Subject's creatinine values higher than 1.6mg/dl. 5. Subject with body mass index, BMI over 30. 6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen. 7. Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery. 8. Subject enrolled in any other cell therapy studies within the past 30 days. 9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above. 10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint. 11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical assessment of Short Form 36 questionnaire (SF-36) | 12 months |
| Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 12 months |
| Clinical assessment of visual analogue scale (VAS) | 12 months |
| Clinical imaging assessment of knee X-ray | 12 months |
| Clinical imaging assessment of MRI of the knee | 12 months |
| Clinical assessment of Hospital for Special Surgery (HSS) Knee Score | 12 months |
Countries
Taiwan
Outcome results
None listed