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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier:
NCT01809769
First received: March 11, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

Two injections in total and 3 ml autologous adipose-tissue-derived progenitor cells(haMPCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection. The trial duration is 3 months.


Condition Intervention Phase
Osteoarthritis
Biological: Mesenchymal progenitor cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Autologous Adipose Tissue Derived Mesenchymal Progenitor Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A Phase I, Prospective, Single-Arm, Dose-escalating Clinical Trial

Resource links provided by NLM:


Further study details as provided by Cellular Biomedicine Group Ltd.:

Primary Outcome Measures:
  • WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recording of Adverse Events and Serious Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • KSCRS Score(The Knee Society Clinical Rating System) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal progenitor cells
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml),2 x 10 E7 cells (3 ml),5 x 10 E7 cells (3 ml). Control: PBS(Placebo) (3 ml). Frequency: 0,3 weeks. Duration:6 months.
Biological: Mesenchymal progenitor cells
Biological: Adipose tissue derived mesenchymal progentior cells administrated for intra-articular use
Other Name: Adipose tissue derived mesenchymal progentior cells

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 the cells (this process takes up to 2 hours). The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809769

Locations
China, Shanghai
Division of Rheumatology,Renji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
Investigators
Principal Investigator: Chunde Bao, M.D. & Ph.D. Division of Rheumatology,Renji Hospital
  More Information

No publications provided

Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT01809769     History of Changes
Other Study ID Numbers: CBMG-KOA-1.1
Study First Received: March 11, 2013
Last Updated: March 19, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014