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Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells (MPCs) Therapy for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02162693
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
RenJi Hospital
General Hospital of Chinese Armed Police Force
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

Tracking Information
First Submitted Date  ICMJE March 19, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE November 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02162693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
Recording of Adverse Events and Serious Adverse Events [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells (MPCs) Therapy for Knee Osteoarthritis
Official Title  ICMJE A PhaseⅡb, Randomized, Double-blinded, Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis
Brief Summary Current medication treatments for KOA aim to relieve inflammation and pain, but they do little to delay or reverse the disease progression and most medications have obvious side effects. When the conservative treatments are useless to patients and joint deformities and joint disfunction, the patients may require surgery. Although surgery of the joints can relieve the pain temporarily, long-term effect (over 10 years) is hard to achieve.
Detailed Description Human adipose-derived mesenchymal progenitor cells (haMPCs) are obtained through a series of procedures: firstly, the fresh adipose tissue is digested with collagenase, filtered, centrifuged and then discard mature adipose cells to obtain adipose tissue-derived nuclear cells also called stromal vascular fraction cells (SVFs). In the end, haMPCs are prepared after being purified andamplified to P2-P5. When induced by specific factors, haMPCs have a potential for multilineage differentiation towards bone, cartilage and fat tissue both in vivo and in vitro. The haMPCs can secrete a number of soluble mediators to stimulate the proliferation of endogenous progenitor cells, to act as nutrients, to be immunosuppressive, to be anti-inflammatory, to prevent fibrosis and promote angiogenesis. The cytokines secreted by haMPCs play a synergic role in restoring the dynamic balance of synthesis and decompositon of cartilage tissue, and finally to repair the impaired cartilage.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Biological: Mesenchymal progenitor cells
    Administrated for intra-articular injection
  • Biological: Sodium Hyaluronate
Study Arms  ICMJE
  • Experimental: Mesenchymal progenitor cells
    Administrated for intra-articular use of Mesenchymal progenitor cells
    Intervention: Biological: Mesenchymal progenitor cells
  • Active Comparator: Sodium Hyaluronate
    Administrated for intra-articular use of Sodium Hyaluronate.
    Intervention: Biological: Sodium Hyaluronate
Publications * Not Provided

*   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: February 9, 2017)
53
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2014)
48
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The subject is between 18-70 years of age, regardless of gender
  2. The subject has a Kellgren-Lawrence grading, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee, below grade 4
  3. The subject or the subject's legally acceptable representative must be willing to participate in the trial, to receive cell therapy and to provide signed and dated informed consent forms

Exclusion Criteria:

  1. The subject has an allergic history or is of an allergic constitution
  2. The subject has uncontrolled or hard-to-control diseases of heart, liver, kidney or lung
  3. The subject has uncontrolled or hard-to-control diseases of cardiovascular or endocrine system
  4. The subject has severe infectious diseases or a malignant tumour
  5. The subject has coagulation disorders
  6. The subject has a BMI of over 30
  7. The subject has used traditional Chinese medicine containing anti-inflammatory agents in the 2 weeks preceding the trial
  8. The subject has received other intra-articular injections in the 2 months preceding the trial
  9. The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articular, Hemochromatosis,inflammatory arthropathy,avascular necrosis of femoral head,Paget's disease,hemophilic arthropathy,infectional arthritis,Charcot's disease,villonodular synovitis or synovial chondromatosis
  10. The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases
  11. The subject has a history of alcoholism, drug abuse, or mental illness
  12. The subject has participated in any other clinical trial in the 3 months prior to this trial
  13. The subject is pregnant, lactating or is planning to conceive within the next 6 months
  14. The subject has any other unsuitable or adverse condition to be determined by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT02162693
Other Study ID Numbers  ICMJE CBMG-KOA-Ⅱb
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
  • General Hospital of Chinese Armed Police Force
Investigators  ICMJE
Principal Investigator: Chunde Bao, MD RenJi Hospital
Principal Investigator: Zhongwen Zhang, MD General Hospital of Chinese Armed Police Force
PRS Account Cellular Biomedicine Group Ltd.
Verification Date November 2017

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