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Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for 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: NCT02641860
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

Tracking Information
First Submitted Date  ICMJE December 21, 2015
First Posted Date  ICMJE December 30, 2015
Last Update Posted Date September 13, 2018
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2018)
  • Safety, recording of Adverse Events and Serious Adverse Events [ Time Frame: 12 weeks,48 weeks ]
  • WOMAC Score [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 24, 2015)
WOMAC Score [ Time Frame: 48 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2018)
  • VAS Score [ Time Frame: 48 weeks ]
  • SF-36 [ Time Frame: 48 Weeks ]
  • The volume of articular cartilage [ Time Frame: 48 weeks ]
  • WORMS Score [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2015)
  • Recording of Adverse Events and Serious Adverse Events [ Time Frame: 48 weeks ]
  • VAS Score [ Time Frame: 48 weeks ]
  • SF-36 [ Time Frame: 48 Weeks ]
  • The volume of articular cartilage [ Time Frame: 48 weeks ]
  • WORMS Score [ Time Frame: 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis
Official Title  ICMJE A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis
Brief Summary Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.
Detailed Description

A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.

This is a randomized,single-blind, double-blinded,phase I clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different dosage group after signing the ICF and screening tests.The treatment will accept Allogenic ReJoinTM at the first and fourth week.The duration of the therapy is 48 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Biological: Mesenchymal progenitor cells
Biological: Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra-articular use
Study Arms  ICMJE
  • Mesenchymal progenitor cells Dosage 1
    Mesenchymal progenitor cells low-dose group
    Intervention: Biological: Mesenchymal progenitor cells
  • Mesenchymal progenitor cells Dosage 2
    Mesenchymal progenitor cells mid-dose group
    Intervention: Biological: Mesenchymal progenitor cells
  • Mesenchymal progenitor cells Dosage 3
    Mesenchymal progenitor cells high-dose group
    Intervention: Biological: Mesenchymal progenitor cells
Publications * Zhao X, Ruan J, Tang H, Li J, Shi Y, Li M, Li S, Xu C, Lu Q, Dai C. Multi-compositional MRI evaluation of repair cartilage in knee osteoarthritis with treatment of allogeneic human adipose-derived mesenchymal progenitor cells. Stem Cell Res Ther. 2019 Oct 21;10(1):308. doi: 10.1186/s13287-019-1406-7.

*   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 12, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: December 24, 2015)
18
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Object has an allergic history or is of an allergic constitution.
  • Subjects who understand and sign the consent form for this study.
  • Age: 18-70, males and females.
  • Clinical diagnosis of degenerative arthritis by Radiographic Criteria of KellgrenLawrence:Duration of pain over Grade 4(11-point numeric scale)> 4 months.
  • Course of Knee osteoarthritis:6 months to 10 years;
  • The VAS score :3-8 points.(the data acquisition time is to stop using all analgesic at least 3 days ).

Exclusion Criteria:

  • The subject has an allergic history of medicine or food。.
  • The subject'BMI is over 30.
  • The subject has uncontrolled or hard-to-control diseases of cardiovascular, liver, kidney or lung, endocrine system.
  • The subject has an history malignant tumour.
  • The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articularis, Hemochromatosis,inflammatory arthropathy,avascular necrosis of femoral head,Paget's disease,hemophilic arthropathy,infectional arthritis,Charcot's disease,villonodular synovitis or synovial chondromatosis.
  • The subject has severe generalized infectious diseases or local knee infection in the 3 months prior to this trial.
  • The subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on.
  • The subject has coagulation disorders.
  • The subject has received arthroscopic surgery or intra-articular operations in the 6 months prior to this trial.
  • The subject has received other intra-articular injections for KOA in the 6 months preceding the trial.
  • The subject has received aminoglucose or chondroitin sulfate in the 6 months preceding the trial.
  • The subject has plan of knee prosthesis within the trial.
  • The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker、defibrillator、heart bracket、heart valve prosthesis、metal clip after aneurysm surgery、drug infusion device implanted in vivo、any electronic device implanted in the body(nerve stimulator、bone growth stimulator)、endovascular coil、strainer、ECG monitor、metal suture、shrapnel or sand of body, plate fixation and steel nail after fracture

    - Page 4 of 4 [DRAFT] - surgery、artificial limb or joint、audiphone、artificial cochlea、middle ear shift plant、metallic intraocular foreign body etc; claustrophobia、pregnancy within 3 months、critically ill patients.

  • The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.
  • The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial.
  • The subject has participated in any other clinical trial in the 3 months prior to this trial.
  • The subject is pregnant, lactating or planning to conceive within the next 6 months.
  • 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 NCT02641860
Other Study ID Numbers  ICMJE CBMG-Allo-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 Not Provided
PRS Account Cellular Biomedicine Group Ltd.
Verification Date September 2018

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