Knee Osteoarthritis
Conditions
Brief summary
Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.
Detailed description
Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).
Interventions
BIOLOGICALMesenchymal stem cells low-dose group
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
BIOLOGICALMesenchymal stem cells mid-dose group
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
BIOLOGICALMesenchymal stem cells high-dose group
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Sponsors
RenJi Hospital
Shanghai AbelZeta Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who understand and sign the consent form for this study. * Age: 40-70, males and females. * Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence. * Patients who can't treat with traditional medication and need a arthroplasty. * Duration of pain over Grade 4(11-point numeric scale)\> 4 months.
Exclusion criteria
* Women who are pregnant or breast feeding or planning to become pregnant during the study. * Objects who administer with a anti-inflammatory drugs within 14 days prior to inclusion in the study. * History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications. * Treatment with intra-articular injection therapy within 2 months prior to screen. * Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis. * Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis. * Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus. * Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II). * Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study. * Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory tests | 9 weeks | Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests |
| Vital signs | 9 weeks | — |
| Physical examination | 9 weeks | — |
| WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) | 24 months | — |
| Recording of Adverse Events and Serious Adverse Events | 12 weeks | — |
| Electrocardiogram | 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS-11 | 24 months |
| The volume of articular cartilage | 24 months |
| SF-36 | 24 months |
Countries
China
Outcome results
None listed