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

NCT02770209 | Unknown DMC

• 1 other identifier: PLAGH_002
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cartilage Diseases

Outcome Measures

Primary Outcomes (1)

• Change of Magnetic resonance imaging(MRI)

  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.

  Before treatment and month 3, month 6, month 12, month 18 after surgery

Secondary Outcomes (4)

• Change of Lysholm score

  Before treatment and month 3, month 6, month 12, month 18 after surgery

• Change of 2000 IKDC subjective knee evaluation score

  Before treatment and month 3, month 6, month 12,month 18 after surgery

• Change of KOOS survey

  Before treatment and month 3, month 6, month 12,month 18 after surgery

• Change of the VAS pain scale

  Before treatment and month 3, month 6, month 12,month 18 after surgery

Study Arms (2)

the experimental group

EXPERIMENTAL

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

the control group

EXPERIMENTAL

Patients in the control group will be subjected to arthroscopic debridement and microfracture surgery.

Procedure: arthroscopic debridement; Procedure: microfracture surgery

Interventions

biomimetic cartilage matrix + autologous chondrocytes BIOLOGICAL

the experimental group

arthroscopic debridement PROCEDURE

the control group

microfracture surgery PROCEDURE

the control group

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Related Publications (1)

• Ma N, Wang H, Xu X, Wan Y, Liu Y, Wang M, Yu W, Dai Y, Peng J, Guo Q, Yu C, Lu S. Autologous-cell-derived, tissue-engineered cartilage for repairing articular cartilage lesions in the knee: study protocol for a randomized controlled trial. Trials. 2017 Nov 6;18(1):519. doi: 10.1186/s13063-017-2251-6.

  PMID: 29110690 DERIVED

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Quanyi Guo, Ph.D

  Institute of Orthopedics, Chinese PLA Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 12, 2016
• Study Start: February 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: June 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05