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UCMSC Transplantation in the Treatment of Cartilage Damage

Primary Purpose

Cartilage Damage, Degenerative Osteoarthritis

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

umbilical cord mesenchymal stem cells

Hyaluronic acid

About this trial

This is an interventional treatment trial for Cartilage Damage

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesenchymal stem cell treatment

Hyaluronic acid treatment

Arm Description

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.

Administer hyaluronic acid (30 mg) in a single injection

Outcomes

Primary Outcome Measures

Knee Function Change and Improvement

Knee assessments will be performed using the following tools: Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Knee Function Change and Improvement

Changes in knee function will be assessed via the IKDC score.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT02776943

First Posted

March 14, 2016

Last Updated

May 16, 2016

Sponsor

South China Research Center for Stem Cell and Regenerative Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02776943

Brief Title

UCMSC Transplantation in the Treatment of Cartilage Damage

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

South China Research Center for Stem Cell and Regenerative Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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。

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cartilage Damage, Degenerative Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mesenchymal stem cell treatment

Arm Type

Experimental

Arm Description

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.

Arm Title

Hyaluronic acid treatment

Arm Type

Active Comparator

Arm Description

Administer hyaluronic acid (30 mg) in a single injection

Intervention Type

Biological

Intervention Name(s)

umbilical cord mesenchymal stem cells

Other Intervention Name(s)

UCMSC

Intervention Type

Device

Intervention Name(s)

Hyaluronic acid

Primary Outcome Measure Information:

Title

Knee Function Change and Improvement

Description

Knee assessments will be performed using the following tools: Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Time Frame

12 months after treatment

Title

Knee Function Change and Improvement

Description

Changes in knee function will be assessed via the IKDC score.

Time Frame

12 months after treatment

Secondary Outcome Measure Information:

Title

Severity of adverse events

Description

Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xuetao Pei, M.D.,Ph.D

Phone

8610-68164807

AMMS0906@163.COM

First Name & Middle Initial & Last Name or Official Title & Degree

Hailei Yao, Ph.D

Phone

8620-89199000

yaohailei@scrm.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

UCMSC Transplantation in the Treatment of Cartilage Damage

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