Clinical trial NCT01809769: Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis
Official title: Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: Shanghai AbelZeta Ltd.
Sponsor class: INDUSTRY
Collaborators: name: RenJi Hospital
First posted: 2013-03-13
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Recording of Adverse Events and Serious Adverse Events
timeFrame: 12 weeks
measure: Electrocardiogram
timeFrame: 9 weeks
measure: Vital signs
timeFrame: 9 weeks
measure: Physical examination
timeFrame: 9 weeks
measure: WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)
timeFrame: 24 months
measure: Laboratory tests
timeFrame: 9 weeks
Secondary outcomes:
measure: SF-36
timeFrame: 24 months
measure: NRS-11
timeFrame: 24 months
measure: The volume of articular cartilage
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
state: Shanghai
Study officials:
affiliation: Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
name: Chunde Bao, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song Y, Du H, Dai C, Zhang L, Li S, Hunter DJ, Lu L, Bao C. Human adipose-derived mesenchymal stem cells for osteoarthritis: a pilot study with long-term follow-up and repeated injections. Regen Med. 2018 Apr;13(3):295-307. doi: 10.2217/rme-2017-0152. Epub 2018 Feb 8.