Status:
COMPLETED
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis
Lead Sponsor:
Shanghai AbelZeta Ltd.
Collaborating Sponsors:
RenJi Hospital
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-70 years
Phase:
PHASE1
PHASE2
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01809769
Start Date
March 1 2013
End Date
July 1 2015
Last Update
April 4 2016
Active Locations (1)
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1
Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
Shanghai, Shanghai Municipality, China, 200127