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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02291926
Other study ID # HYK-Articular Cartilage Defect
Secondary ID
Status Completed
Phase Phase 1
First received November 7, 2014
Last updated May 8, 2017
Start date December 2014
Est. completion date December 2016

Study information

Verified date July 2015
Source Shenzhen Hornetcorn Bio-technology Company, LTD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells.

To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Human umbilical cord mesenchymal stem cells
A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.

Locations

Country Name City State
China The Fifth Affiliated Hospital Immunotherapy center Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD The Fifth Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Magnetic resonance imaging (MRI) of the knee The size, depth of cartilage defect, and regenerated cartilage were measured using MRI. Before and 1,3,6,12 month after treatment
Secondary Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Change in WOMAC pain score,composite score and function and stiffness index scores. Before and 1,3,6,12 month after treatment
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