Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

Phase 1

Completed

• Conditions: Osteoarthritis; Cartilage Diseases
• Interventions: Biological: Human umbilical cord mesenchymal stem cells

• Registration Number: NCT02291926
• Lead Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

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 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.

Study Timeline

• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Study Start: 2014-12
• Status Verified: 2015-07
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hUC-MSC treatment	Human umbilical cord mesenchymal stem cells	Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Primary Outcome Measures

Name	Time	Method
Severity of adverse events	12 months	Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Fifth Affiliated Hospital Immunotherapy center; 🇨🇳 Guangzhou, Guangdong, China