Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis

Cellular Biomedicine Group

Status and phase: Completed; Phase 2; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Biological: Mesenchymal stem cells high-dose group; Biological: Mesenchymal stem cells low-dose group; Biological: Mesenchymal stem cells mid-dose group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01809769

CBMG-KOA-1.1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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18 participants in 3 patient groups

Mesenchymal stem cells low-dose group

Experimental group

Description:

Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks.

Treatment:

Biological: Mesenchymal stem cells low-dose group

Mesenchymal stem cells mid-dose group

Experimental group

Description:

Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.

Treatment:

Biological: Mesenchymal stem cells mid-dose group

Mesenchymal stem cells high-dose group

Experimental group

Description:

Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.

Treatment:

Biological: Mesenchymal stem cells high-dose group