UCMSC Transplantation in the Treatment of Cartilage Damage

Cartilage Damage Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02776943
• Other study ID #: UCMSC-4
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: March 14, 2016
• Last updated: May 16, 2016
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: January 2016
• Source: South China Research Center for Stem Cell and Regenerative Medicine
• Contact: Xuetao Pei, M.D.,Ph.D
• Phone: 8610-68164807
• Email: AMMS0906[@]163.COM
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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。

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cartilage Damage
• Degenerative Osteoarthritis
• Osteoarthritis

Intervention

Biological:
• umbilical cord mesenchymal stem cells

Device:
• Hyaluronic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South China Research Center for Stem Cell and Regenerative Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Function Change and Improvement	Knee assessments will be performed using the following tools: Western Ontario and McMaster Universities Arthritis Index (WOMAC)	12 months after treatment	No
Primary	Knee Function Change and Improvement	Changes in knee function will be assessed via the IKDC score.	12 months after treatment	No
Secondary	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	Yes