Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

Osteoarthritis Clinical Trial

Official title:

Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291926
• Other study ID #: HYK-Articular Cartilage Defect
• 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
• 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

Related Conditions & MeSH terms

• Cartilage Diseases
• Osteoarthritis

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