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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01809769
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : April 4, 2016
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

Tracking Information
First Submitted Date  ICMJE March 11, 2013
First Posted Date  ICMJE March 13, 2013
Last Update Posted Date April 4, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
  • Recording of Adverse Events and Serious Adverse Events [ Time Frame: 12 weeks ]
  • Electrocardiogram [ Time Frame: 9 weeks ]
  • Vital signs [ Time Frame: 9 weeks ]
  • Physical examination [ Time Frame: 9 weeks ]
  • WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) [ Time Frame: 24 months ]
  • Laboratory tests [ Time Frame: 9 weeks ]
    Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
  • SF-36 [ Time Frame: 24 months ]
  • NRS-11 [ Time Frame: 24 months ]
  • The volume of articular cartilage [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
Recording of Adverse Events and Serious Adverse Events [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 11, 2013)
KSCRS Score(The Knee Society Clinical Rating System) [ Time Frame: 6 months ]
 
Descriptive Information
Brief Title  ICMJE Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Biological: Mesenchymal stem cells low-dose group
    Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
    Other Name: Adipose tissue derived mesenchymal stem cells
  • Biological: Mesenchymal stem cells mid-dose group
    Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
    Other Name: Adipose tissue derived mesenchymal stem cells
  • Biological: Mesenchymal stem cells high-dose group
    Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
    Other Name: Adipose tissue derived mesenchymal stem cells
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Biological: Mesenchymal stem cells low-dose group
  • Experimental: 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.
    Intervention: Biological: Mesenchymal stem cells mid-dose group
  • Experimental: 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.
    Intervention: Biological: Mesenchymal stem cells high-dose group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2013)
18
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2013)
120
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809769
Other Study ID Numbers  ICMJE CBMG-KOA-1.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cellular Biomedicine Group Ltd.
Study Sponsor  ICMJE Cellular Biomedicine Group Ltd.
Collaborators  ICMJE RenJi Hospital
Investigators  ICMJE
Principal Investigator: Chunde Bao, M.D. & Ph.D. Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
PRS Account Cellular Biomedicine Group Ltd.
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP