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

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

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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 |
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

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
Contact: Xuetao Pei, M.D.,Ph.D | 8610-68164807 | AMMS0906@163.COM | |
Contact: Hailei Yao, Ph.D | 8620-89199000 | yaohailei@scrm.org.cn |
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 |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Hyaluronic Acid |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |