UCMSC Transplantation in the Treatment of Cartilage Damage
Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee and Knee Osteoarthritis
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2016
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
May 18, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMay 18, 2016
January 1, 2016
2.5 years
March 14, 2016
May 16, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Knee Function Change and Improvement
Knee assessments will be performed using the following tools: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
12 months after treatment
Knee Function Change and Improvement
Changes in knee function will be assessed via the IKDC score.
12 months after treatment
Secondary Outcomes (1)
Severity of adverse events
12 months
Study Arms (2)
Mesenchymal stem cell treatment
EXPERIMENTALUmbilical 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.
Hyaluronic acid treatment
ACTIVE COMPARATORAdminister hyaluronic acid (30 mg) in a single injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2016
First Posted
May 18, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2018
Study Completion
June 1, 2019
Last Updated
May 18, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share