Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect
Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee
1 other identifier
interventional
20
1 country
1
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.
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 Dec 2014
Typical duration for phase_1
1 active site
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
November 7, 2014
CompletedFirst Posted
Study publicly available on registry
November 17, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 10, 2017
July 1, 2015
1.6 years
November 7, 2014
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
12 months
Secondary Outcomes (2)
Magnetic resonance imaging (MRI) of the knee
Before and 1,3,6,12 month after treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Before and 1,3,6,12 month after treatment
Study Arms (1)
hUC-MSC treatment
EXPERIMENTALPatients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Interventions
A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fifth Affiliated Hospital Immunotherapy center
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ping J Chen, Professor
Fifth Affiliated Hospital of Guangzhou Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2014
First Posted
November 17, 2014
Study Start
December 1, 2014
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
May 10, 2017
Record last verified: 2015-07