Guided Cartilage Regeneration Membrane (GCRM)

Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury

Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Ligament Injury; Articular Cartilage Injury
• Intervention / Treatment: Combination product: Guided cartilage regeneration membrane; Procedure: Microfracture

Detailed Description

MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe the improvement of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingfang Ao, PhD; Phone Number: 13401096777 13401096777; Email: gcrm_bys01@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100853
      • Chinese PLA General Hospital
      • Contact: Zhongli Li, PhD
      • Principal Investigator: Zhongli Li, PhD
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Zunyi Medical College
      • Contact: Yi Liu, Bachelor
      • Sub-Investigator: Hehe Zhong, PhD
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Jianzhong Xu, PhD
      • Principal Investigator: Jianzhong Xu, PhD
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital
      • Contact: Liaobin Chen, PhD
      • Sub-Investigator: Biao Chen, PhD
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Contact: Qing Jiang, PhD
      • Sub-Investigator: Jin Dai, PhD
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Second Hospital of Shanxi Medical University
      • Contact: Zhiqiang Zhang, Postgraduate
      • Sub-Investigator: Junjun Shi, PhD
    • Xi'an, Shanxi, China, 710000
      • Xi'an Honghui Hospital
      • Contact: Jiang Zheng, PhD
      • Principal Investigator: Jiang Zheng, PhD
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • The First Affiliated Hospital of Kunming Medical College
      • Contact: Yanlin Li, PhD
      • Principal Investigator: Yanlin Li, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥18 years old and ≤50 years old, regardless of gender
2. 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery
3. Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up

Exclusion Criteria:

1. Those who have participated in clinical trials of other drugs or medical devices in the last 6 months
2. Those with stage III or above degeneration of bone and joint
3. Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues
4. Those who are sensitive to collagen, foreign protein or pig-derived materials
5. Repair the damaged area> 8 cm2 or <2 cm2, lack of normal cartilage tissue around the injury

6. Severe heart, liver and kidney insufficiency are defined as:

   Heart function: NYHA grade III or above; ALT, AST> 2.5 times the upper limit of normal value; Serum creatinine> 1.5 times the upper limit of normal value;

7. People with systemic immune diseases or systemic or local infections
8. Joint fibrosis, joint stiffness, and obviously restricted movement
9. Those with moderate or severe osteoarthritis
10. People with contraindications for MRI examination
11. Patients with hemophilia
12. Those who cannot tolerate surgery
13. Women who are pregnant or plan to become pregnant and breastfeeding women
14. Persons with mental abnormalities and incapacity to act autonomously
15. Other conditions that the doctor judges cannot participate in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cartilage membrane surgery; The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd. Cartilage regeneration membrane combined with microfracture surgery.	Combination product: Guided cartilage regeneration membrane; On the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot.; Procedure: Microfracture; Operate in accordance with the clinical microfracture surgery method.
Other: Microfracture; The control group was treated with microfractures widely recognized at home and abroad.	Procedure: Microfracture; Operate in accordance with the clinical microfracture surgery method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI evaluation of articular cartilage injury 730 days (2 years) after repair	The nuclear magnetic evaluation indicators are as follows: Cartilage defect repair filling degree;; Fusion of repair tissue and adjacent normal cartilage;; Repair tissue surface structure;; Repair the internal structure of the organization. The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group.	End of surgery to 730 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value	The closer the ratio of the regenerated cartilage T2 value to the normal control cartilage T2 value is 1, it means that the regenerated cartilage The closer the water content and collagen arrangement are to normal cartilage.	At 24 months after surgery
Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value	The closer the ratio of the regenerated cartilage △R1 value to the normal control cartilage △R1 value is 1, it means that the GAG content of regenerated cartilage is closer to normal cartilage.	At 24 months after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Chinese PLA General Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhengzhou University; Zhongnan Hospital; The First Affiliated Hospital of Kunming Medical College; Second Hospital of Shanxi Medical University; Zunyi Medical College; Xi'an Honghui Hospital
• Investigators: Principal Investigator: Yingfang Ao, PhD, Department of Sports Medicine, Peking University Third Hospital; Study Director: Xiaoqing Hu, PhD, Department of Sports Medicine, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 3, 2020
• Primary Completion (Anticipated): August 3, 2022
• Study Completion (Anticipated): August 3, 2023

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 3, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2015035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No