Clinical Trial: Autologous Cell-derived Tissue Engineered Cartilage for Repairing Articular Cartilage Lesions

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Autologous Cell-derived Tissue Engineered Cartilage for Repairing Articular Cartilage Lesions: a Protocol for a Prospective, Randomized, Controlled Clinical Trial

Brief Summary: This study is aimed at evaluating the feasibility and effectiveness of a completely natural tissue engineered cartilage, composed of a self-made tissue engineered oriented scaffold and autologous chondrocytes, for repairing articular cartilage damage following injury. And it is also aimed at investigating the safety of tissue engineered cartilage transplantation.

Detailed Summary:

Injured articular cartilage has limited capacity for self repair. Without timely, early and effective treatment, damage to the articular cartilage progressively worsens, resulting in joint swelling, pain and dysfunction. The patient ultimately develops osteoarthritis and will be required to undergo artificial joint replacement. Clinical therapy for cartilage damage includes microfracture surgery and autologous osteochondral transplantation. However, the microfracture technique is limited to small-scale damage, and autologous osteochondral transplantation is hindered by limited supply. With advances in material science, cell biology, biomechanics and bioreactor technology, the new generation of biomimetic tissue engineered osteochondral composites display great potential for the repair of cartilage damage.

Currently, in cartilage tissue engineering, seed cells are derived from autologous or allogeneic chondrocytes, mesenchymal stem cells, embryonic stem cells or pluripotent stem cells. Increasing evidence indicates that bone marrow mesenchymal stem cells can be induced to differentiate into chondrocytes, and these cells have been successfully used in the treatment of large-size bone defects, cartilage lesions and spinal cord injury. The quality and quantity of bone mesenchymal stem cells gradually decrease with age, especially in patients with degenerative diseases. Adipose stem cells and umbilical cord mesenchymal stem cells are abundant and have similar characteristics to bone mesenchymal stem cells, and both of these cell types can be induced to differentiate into chondrocytes. Adipose stem cells and umbilical cord mesenchymal stem cells have been used to repair cartilage defects, but the findings are still preliminary, and these cells cannot be harvested or cultured in large quantities. Furthermore, the use of embryonic stem cells is complicated by ethical consideratio
Sponsor: Chinese PLA General Hospital

Current Primary Outcome: Change of Magnetic resonance imaging(MRI) [ Time Frame: Before treatment and month 3, month 6, month 12, month 18 after surgery ]

using joint MRI, cartilage thickness and fusion with surrounding normal cartilage and subchondral bone, as well as the presence or absence of articular effusion and subchondral bone edema will be assessed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change of Lysholm score [ Time Frame: Before treatment and month 3, month 6, month 12, month 18 after surgery ]
    The Lysholm score is out of a possible 100 points.
  • Change of 2000 IKDC subjective knee evaluation score [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
    A higher score indicates better knee function. IKDC score is used to evaluate knee function and symptoms. 100 points represents no restrictions of daily life and sports.
  • Change of KOOS survey [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
  • Change of the VAS pain scale [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
    Joint pain will be evaluated with the VAS pain scale; 0 = painless, 10 = severe pain.


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: May 11, 2016
Date Started: February 2012
Date Completion: June 2016
Last Updated: May 11, 2016
Last Verified: May 2016