UCMSC Transplantation in the Treatment of Cartilage Damage
Primary Purpose
Cartilage Damage, Degenerative Osteoarthritis
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
umbilical cord mesenchymal stem cells
Hyaluronic acid
Sponsored by

About this trial
This is an interventional treatment trial for Cartilage Damage
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mesenchymal stem cell treatment
Hyaluronic acid treatment
Arm Description
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.
Administer hyaluronic acid (30 mg) in a single injection
Outcomes
Primary Outcome Measures
Knee Function Change and Improvement
Knee assessments will be performed using the following tools:
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Knee Function Change and Improvement
Changes in knee function will be assessed via the IKDC score.
Secondary Outcome Measures
Severity of adverse events
Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0)
Full Information
NCT ID
NCT02776943
First Posted
March 14, 2016
Last Updated
May 16, 2016
Sponsor
South China Research Center for Stem Cell and Regenerative Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02776943
Brief Title
UCMSC Transplantation in the Treatment of Cartilage Damage
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South China Research Center for Stem Cell and Regenerative Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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。
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Damage, Degenerative Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal stem cell treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Hyaluronic acid treatment
Arm Type
Active Comparator
Arm Description
Administer hyaluronic acid (30 mg) in a single injection
Intervention Type
Biological
Intervention Name(s)
umbilical cord mesenchymal stem cells
Other Intervention Name(s)
UCMSC
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid
Primary Outcome Measure Information:
Title
Knee Function Change and Improvement
Description
Knee assessments will be performed using the following tools:
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
12 months after treatment
Title
Knee Function Change and Improvement
Description
Changes in knee function will be assessed via the IKDC score.
Time Frame
12 months after treatment
Secondary Outcome Measure Information:
Title
Severity of adverse events
Description
Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuetao Pei, M.D.,Ph.D
Phone
8610-68164807
Email
AMMS0906@163.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Hailei Yao, Ph.D
Phone
8620-89199000
Email
yaohailei@scrm.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
UCMSC Transplantation in the Treatment of Cartilage Damage
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