Tissue Engineered Cartilage to Repairing Articular Cartilage Defects

April 28, 2026 updated by: The First Affiliated Hospital of Xinxiang Medical College

Clinical Study of Cartilage Constructed by Autologous Bone Marrow Mesenchymal Stem Cells in Repairing Articular Cartilage Defects

The joint cartilage constructed by combining bone marrow mesenchymal stem cells with three-dimensional materials has achieved the goal of repairing joint cartilage.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Trauma, degeneration, inflammation, tumors, etc. can all cause damage to the cartilage of human joints. The cartilage has an extremely low self-repairing ability. Once damaged, the damage will become more and more severe over time, accelerating the occurrence and development of osteoarthritis, and causing varying degrees of joint dysfunction and reduced quality of life. Currently, traditional surgical treatments such as joint debridement, microfracture, and mosaic cartilage transplantation only apply to small-scale cartilage injuries, and long-term follow-up has found that the results are not satisfactory. The breakthrough in the core technology of in vitro constructing living cartilage based on tissue engineering principles has brought new hope for the physiological function reconstruction of joint cartilage damage. Cartilage was the first tissue to successfully regenerate using tissue engineering technology, but due to the limitation of the source of seed cells, no significant clinical breakthrough has been achieved. Studies have shown that bone marrow mesenchymal stem cells (BMSCs) are a type of cell with multi-directional differentiation potential (including cartilage and bone differentiation potential). Due to the fact that BMSCs can be autologously collected, the trauma is minimal, and the in vitro expansion ability is strong, therefore, they can meet the dual requirements of "quality and quantity" of seed cells for tissue engineering cartilage, and are very suitable for clinical application in the field of joint cartilage repair. More importantly, BMSCs have good cartilage formation ability. Our research group has established and invented a series of key technologies and methods for inducing BMSCs to form cartilage in vivo and in vitro in previous studies, and by applying BMSCs combined with three-dimensional degradable scaffold materials, we have been able to construct cartilage with a certain volume and morphology even biological joint tissues in vitro. At the same time, the application of autologous BMSCs for in vitro regeneration of cartilage has successfully repaired joint cartilage and bone composite defects in large animals, and especially has successfully carried out the exploratory clinical research of "in vitro construction of cartilage using autologous bone marrow mesenchymal stem cells for repairing joint cartilage defects", and after a 5-year follow-up, it has been confirmed that this technology can achieve satisfactory clinical repair effects. The research purpose of this application project is to use BMSCs combined with three-dimensional materials to construct joint cartilage to achieve the goal of repairing joint cartilage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Henan
      • Xinxiang, Henan, China, 453000
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical College
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patients' age ranges from 18 to 65 years old, and gender is not restricted;
  2. The imaging results show that the epiphyseal growth is mature;
  3. The defects or localized injuries of joint cartilage caused by trauma or other reasons;
  4. The injured area is the distal weight-bearing surface of the femoral condyle of the knee joint, with no more than 4 lesions, and there is no injury to the cruciate ligaments;
  5. The patients voluntarily sign and provide a written informed consent form and are willing to closely cooperate with the doctor's strict postoperative rehabilitation program.

Exclusion Criteria:

  1. The patient is extremely overweight, with a body mass index greater than 35;
  2. The lower limb alignment is valgus by more than 10° and varus by more than 5°;
  3. Multiple ligament injuries;
  4. There are numerous bad habits such as heavy smoking, drug abuse, and excessive alcohol consumption;
  5. Has undergone open knee joint surgery within the past six months;
  6. Has severe joint stiffness or fibrosis;
  7. Has an allergic constitution or a history of allergic reactions to collagen;
  8. Has mental abnormalities;
  9. Cannot or is unwilling to undergo rehabilitation training;
  10. Has primary cardiovascular diseases, lung diseases, endocrine and metabolic disorders, or other serious diseases that affect their daily life, such as tumors or AIDS;
  11. Pregnant or lactating women, or those planning to conceive during the trial period;
  12. Other acute or chronic diseases, for which the researchers consider surgery to be inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tissue-engineered cartilage to repair articular cartilage defects
Device: Tissue engineered cartilage
Cartilage constructed by autologous bone marrow mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
KSS score
Time Frame: before the operation, at 3, 6, 12 and 24 months after the operation.
subjective knee clinical and functional score (0-100)score.100 is better in function
before the operation, at 3, 6, 12 and 24 months after the operation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Koos scores
Time Frame: before the operation, at 3, 6, 12 and 24 months after the operation.
subjective knee functional score (0-100)score.100 is better in function
before the operation, at 3, 6, 12 and 24 months after the operation.
Lysholm score
Time Frame: before the operation, at 3, 6, 12 and 24 months after the operation.
subjective knee functional score (0-100)score.100 is better in function
before the operation, at 3, 6, 12 and 24 months after the operation.
WOMAC score
Time Frame: before the operation, at 3, 6, 12 and 24 months after the operation.
The higher the index, the more severe the osteoarthritis. It is less than 80 for mild cases, 80 to 120 for moderate cases, and more than 120 for severe cases.
before the operation, at 3, 6, 12 and 24 months after the operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Xinxiang Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TECOA-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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