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Completed

NCT Number: NCT02291926

Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Fifth Affiliated Hospital Immunotherapy center

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human umbilical cord mesenchymal stem cells

Biological

A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.

Other names: hUC-MSC

Primary outcomes

  1. Severity of adverse events

    Time frame: 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 outcomes

  1. Magnetic resonance imaging (MRI) of the knee

    Time frame: Before and 1,3,6,12 month after treatment

    The size, depth of cartilage defect, and regenerated cartilage were measured using MRI.

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Before and 1,3,6,12 month after treatment

    Change in WOMAC pain score,composite score and function and stiffness index scores.

Sponsors and collaborators

Lead sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD

Industry

Collaborators

  • Fifth Affiliated Hospital of Guangzhou Medical University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2014
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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