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

NCT ID: NCT01809769

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-07-31

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).

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mesenchymal stem cells low-dose group

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

Group Type: EXPERIMENTAL

Mesenchymal stem cells low-dose group

Intervention Type: BIOLOGICAL

Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

Mesenchymal stem cells mid-dose group

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

Group Type: EXPERIMENTAL

Mesenchymal stem cells mid-dose group

Intervention Type: BIOLOGICAL

Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

Mesenchymal stem cells high-dose group

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

Group Type: EXPERIMENTAL

Mesenchymal stem cells high-dose group

Intervention Type: BIOLOGICAL

Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

Interventions

Mesenchymal stem cells low-dose group

Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

Intervention Type: BIOLOGICAL

Mesenchymal stem cells mid-dose group

Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

Intervention Type: BIOLOGICAL

Mesenchymal stem cells high-dose group

Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

Intervention Type: BIOLOGICAL

Other Intervention Names

Adipose tissue derived mesenchymal stem cells; Adipose tissue derived mesenchymal stem cells; Adipose tissue derived mesenchymal stem cells

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunde Bao, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China

Locations

Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 29417902 (View on PubMed)

Other Identifiers

CBMG-KOA-1.1

Identifier Type: -

Identifier Source: org_study_id