UCMSC Transplantation in the Treatment of Cartilage Damage

May 16, 2016 updated by: South China Research Center for Stem Cell and Regenerative Medicine

Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee and Knee Osteoarthritis

The purpose of this study is to investigate the efficacy and safety of transplantation of umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Human cartilage only has limited regenerative potential. Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of ucMSCs does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety。

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients whose lesion (single joint) should be in the range of 2 cm^2-8 cm^2.
  • Patients with pain in affected joint of 60 mm- 100 mm VAS (visual analogue scale)
  • Patients with articular swelling, tenderness and active range of motion of Grade 2 or below
  • Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included)
  • Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
  • Patients voluntarily agreed to participate in the study and signed informed consent

Exclusion Criteria:

  • Patients with autoimmune diseases or medical history
  • Patients with infections requiring injection of antibiotics
  • Patients with severe internal diseases
  • Patients who are currently pregnant or lactation
  • Patients who had participated in any other clinical trials within the past four weeks
  • Patients who had been administered with immunosuppressants within the past four weeks
  • Patients whom the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mesenchymal stem cell treatment
Umbilical Cord Mesenchymal stem cells (UCMSC) expanded and treated for 1-2 weeks. Then administer 5x10^6 of UCMSC per cm^2 of the cartilage defect.
Biological: umbilical cord mesenchymal stem cells
Other Names:
  • UCMSC
ACTIVE_COMPARATOR: Hyaluronic acid treatment
Administer hyaluronic acid (30 mg) in a single injection
Device: Hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Function Change and Improvement
Time Frame: 12 months after treatment

Knee assessments will be performed using the following tools:

Western Ontario and McMaster Universities Arthritis Index (WOMAC)
12 months after treatment
Knee Function Change and Improvement
Time Frame: 12 months after treatment
Changes in knee function will be assessed via the IKDC score.
12 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South China Research Center for Stem Cell and Regenerative Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

May 16, 2016

First Posted (ESTIMATE)

May 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCMSC-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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