UCMSC Transplantation in the Treatment of Cartilage Damage

NCT ID: NCT02776943

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-06-30

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。

Conditions

Cartilage Damage; Degenerative Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

Hyaluronic acid treatment

Administer hyaluronic acid (30 mg) in a single injection

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type: DEVICE

Interventions

umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

Hyaluronic acid

Intervention Type: DEVICE

Other Intervention Names

UCMSC

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South China Research Center for Stem Cell and Regenerative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xuetao Pei, M.D.,Ph.D

Role: CONTACT

AMMS0906@163.COM

8610-68164807

Hailei Yao, Ph.D

Role: CONTACT

yaohailei@scrm.org.cn

8620-89199000

Other Identifiers

UCMSC-4

Identifier Type: -

Identifier Source: org_study_id