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UCMSC Transplantation in the Treatment of Cartilage Damage

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ClinicalTrials.gov Identifier: NCT02776943
Recruitment Status : Unknown
Verified January 2016 by South China Research Center for Stem Cell and Regenerative Medicine.
Recruitment status was:  Not yet recruiting
First Posted : May 18, 2016
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
South China Research Center for Stem Cell and Regenerative Medicine

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE May 18, 2016
Last Update Posted Date May 18, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2016)
  • Knee Function Change and Improvement [ Time Frame: 12 months after treatment ]
    Knee assessments will be performed using the following tools: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
  • Knee Function Change and Improvement [ Time Frame: 12 months after treatment ]
    Changes in knee function will be assessed via the IKDC score.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2016)
Severity of adverse events [ Time Frame: 12 months ]
Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0)
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 UCMSC Transplantation in the Treatment of Cartilage Damage
Official Title  ICMJE Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee and Knee Osteoarthritis
Brief Summary The purpose of this study is to investigate the efficacy and safety of transplantation of umbilical cord mesenchymal stem cells(UCMSCs) in patient with Knee cartilage damage.
Detailed Description Human cartilage only has limited regenerative potential. Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of ucMSCs does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety。
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cartilage Damage
  • Degenerative Osteoarthritis
Intervention  ICMJE
  • Biological: umbilical cord mesenchymal stem cells
    Other Name: UCMSC
  • Device: Hyaluronic acid
Study Arms  ICMJE
  • Experimental: Mesenchymal stem cell treatment
    Umbilical Cord Mesenchymal stem cells (UCMSC) expanded and treated for 1-2 weeks. Then administer 5x10^6 of UCMSC per cm^2 of the cartilage defect.
    Intervention: Biological: umbilical cord mesenchymal stem cells
  • Active Comparator: Hyaluronic acid treatment
    Administer hyaluronic acid (30 mg) in a single injection
    Intervention: Device: Hyaluronic acid
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 16, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients whose lesion (single joint) should be in the range of 2 cm^2-8 cm^2.
  • Patients with pain in affected joint of 60 mm- 100 mm VAS (visual analogue scale)
  • Patients with articular swelling, tenderness and active range of motion of Grade 2 or below
  • Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included)
  • Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
  • Patients voluntarily agreed to participate in the study and signed informed consent

Exclusion Criteria:

  • Patients with autoimmune diseases or medical history
  • Patients with infections requiring injection of antibiotics
  • Patients with severe internal diseases
  • Patients who are currently pregnant or lactation
  • Patients who had participated in any other clinical trials within the past four weeks
  • Patients who had been administered with immunosuppressants within the past four weeks
  • Patients whom the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02776943
Other Study ID Numbers  ICMJE UCMSC-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party South China Research Center for Stem Cell and Regenerative Medicine
Study Sponsor  ICMJE South China Research Center for Stem Cell and Regenerative Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account South China Research Center for Stem Cell and Regenerative Medicine
Verification Date January 2016

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