Status:
COMPLETED
Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect
Lead Sponsor:
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborating Sponsors:
Fifth Affiliated Hospital of Guangzhou Medical University
Conditions:
Cartilage Diseases
Osteoarthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.
Detailed Description
Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However t...
Eligibility Criteria
Inclusion
- Patients must consent in writing to participate in the study by signing and dating an informed consent document
- Healthy patients with no major history of illness
- Patients must have a diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
- Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
- Patients must have had more than Grade 4 (0\~10 point numeric scale) pain at least for four months
- Patient's damaged cartilage area should be in the range of 2-6cm2
Exclusion
- Pregnant women or lactating mothers
- Patients who have received any anti-inflammatory drugs including herb-drug within 14 days
- Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment
- Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection
- Impaired liver function, abnormal blood coagulation, combine other tumor or special condition
- Patients who had participated in other clinical trials within three months prior to this study
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02291926
Start Date
December 1 2014
End Date
December 1 2016
Last Update
May 10 2017
Active Locations (1)
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1
The Fifth Affiliated Hospital Immunotherapy center
Guangzhou, Guangdong, China, 510000