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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cartilage Damage Degenerative Osteoarthritis Biological: umbilical cord mesenchymal stem cells Device: Hyaluronic acid Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee and Knee Osteoarthritis
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: umbilical cord mesenchymal stem cells
Other Name: UCMSC
Active Comparator: Hyaluronic acid treatment
Administer hyaluronic acid (30 mg) in a single injection
 Device: Hyaluronic acid


Outcome Measures
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Primary Outcome Measures :
  1. 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)


  2. Knee Function Change and Improvement [ Time Frame: 12 months after treatment ]
    Changes in knee function will be assessed via the IKDC score.


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776943


Contacts
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Contact: Xuetao Pei, M.D.,Ph.D 8610-68164807 AMMS0906@163.COM
Contact: Hailei Yao, Ph.D 8620-89199000 yaohailei@scrm.org.cn

Sponsors and Collaborators
South China Research Center for Stem Cell and Regenerative Medicine
More Information
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Responsible Party: South China Research Center for Stem Cell and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT02776943    
Other Study ID Numbers: UCMSC-4
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents