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
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 April 16, 2014