Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

Shenzhen Hornetcorn Biotechnology

Status and phase: Completed; Phase 1

Conditions: Cartilage Diseases; Osteoarthritis

Treatments: Biological: Human umbilical cord mesenchymal stem cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02291926

HYK-Articular Cartilage Defect

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

hUC-MSC treatment

Experimental group

Description:

Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Treatment:

Biological: Human umbilical cord mesenchymal stem cells