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Autologous Cell-derived Tissue Engineered Cartilage for Repairing Articular Cartilage Lesions

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ClinicalTrials.gov Identifier: NCT02770209
Recruitment Status : Unknown
Verified May 2016 by Quanyi Guo, Chinese PLA General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Quanyi Guo, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
Cartilage Diseases Biological: biomimetic cartilage matrix + autologous chondrocytes Procedure: arthroscopic debridement Procedure: microfracture surgery Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Autologous Cell-derived Tissue Engineered Cartilage for Repairing Articular Cartilage Lesions: a Protocol for a Prospective, Randomized, Controlled Clinical Trial
Study Start Date : February 2012
Actual Primary Completion Date : August 2013
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: the experimental group
Patients in the experimental group will be treated with the biomimetic cartilage matrix combined with autologous chondrocytes. The entire course of treatment includes two surgeries. The first surgery will be performed to observe articular cartilage damage by arthroscopy and assess treatment potential. If the patient's condition meets the surgical requirement, we will extract cartilage from the fossa intercondylar non-weight-bearing area during the first surgery. Chondrocytes will be in vitro-amplified and inoculated into the cartilage scaffold. The fully prepared seeded scaffold will be implanted into the site of injury during the second surgery.
Biological: biomimetic cartilage matrix + autologous chondrocytes
Experimental: the control group
Patients in the control group will be subjected to arthroscopic debridement and microfracture surgery.
Procedure: arthroscopic debridement
Procedure: microfracture surgery



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change of KOOS survey [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
  4. 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.



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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with full-thickness cartilage injury in knee and ankle joints
  • Patients with normal joint movement and stable joint (without injury or less than 1/3 excision of the meniscus; normal cruciate ligament, lateral and medial collateral accessory ligament, or normal Q angle and patellofemoral joint trajectory after transplantation, or corrected to normal by surgery), without valgus or varus deformity
  • Patients 14-50 years of age.
  • Patients with focal cartilage defects diagnosed by arthroscopy, Outerbridge III/IV grade, cartilage defect size 2.5-10 cm2, intact articular surface (lower than grade II injury according to Outerbridge classification), one or two lesions in the same joint.
  • Patients and their families are informed of the treatment and provide signed informed consent.

Exclusion Criteria:

  • Poor health
  • Blood diseases
  • Topical steroid therapy within three months
  • Bleeding tendency
  • Drug addiction (including narcotic, anesthetic or alcohol addiction)
  • Inflammatory joint disease (specific or non-specific arthritis)
  • Contagious viral infection
  • Metabolic diseases (gout or rheumatism)
  • Body mass index > 30 kg/m2
  • Pregnant or lactating women, or planning to become pregnant within 1 year after initial registration
  • Psychological mental illness, cannot cope with rehabilitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770209


Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Principal Investigator: Quanyi Guo, Ph.D Institute of Orthopedics, Chinese PLA Hospital, Beijing, China

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Quanyi Guo, Director, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02770209     History of Changes
Other Study ID Numbers: PLAGH_002
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases