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New treatment option for Traumatic Cartilage Injury
Official title Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue
ClinicalTrials.gov ID: NCT06400862
What this study is testing
What is eOCT implantation?
eOCT implantation is an investigational medicine, being studied as a potential treatment for traumatic cartilage injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of the study is to establish the safety profile of the autologous engineered osteochondral tissues (eOCT) in treating traumatic chondral lesions in patients.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Age: people who are in the age range of 18-60 years
- Location: Single symptomatic cartilage defect on medial or lateral femoral condyle
- Size \& Containment: Contained single focal cartilage lesion of size \~1-4 cm square
- Grading: Cartilage damage ICRS/Outerbridge grade III/IV reaching subchondral bone (As diagnosed by MRI)
- Conservative treatments failed (for \> 4 months)
You likely can't join if
- Disease Factor---
- Previous cartilage repair surgery (OATS or ACI/MACI) in the index knee
- Previous injectional treatments such as HA/PRP/stem cell in the index knee within 3 months before informed consent
- Presence of a clinically relevant patellofemoral cartilage lesion in the index knee (patella/trochlea/both)
- Inflammatory joint disease (specific or non-specific arthritis)
- Metabolic diseases (gout or rheumatism)
See the full eligibility criteria
- Age: people who are in the age range of 18-60 years
- Location: Single symptomatic cartilage defect on medial or lateral femoral condyle
- Size \& Containment: Contained single focal cartilage lesion of size \~1-4 cm square
- Grading: Cartilage damage ICRS/Outerbridge grade III/IV reaching subchondral bone (As diagnosed by MRI)
- Conservative treatments failed (for \> 4 months)
- Disease Factor---
- Previous cartilage repair surgery (OATS or ACI/MACI) in the index knee
- Previous injectional treatments such as HA/PRP/stem cell in the index knee within 3 months before informed consent
- Presence of a clinically relevant patellofemoral cartilage lesion in the index knee (patella/trochlea/both)
- Inflammatory joint disease (specific or non-specific arthritis)
- Metabolic diseases (gout or rheumatism)
- Advanced Osteoarthritis (Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren \& Lawrence Grade \>2)
- Osteochondritis dissecans
- Multiple or uncontained lesions as detected by MRI or arthroscopy
- Uncorrected ligament deficiency
- Uncorrected varus or valgus malalignment exceeding 5°
- Ongoing Infection or skin diseases at target knee joint
- Significant meniscal loss Patient Factor---
- people who are not able or not willing to give voluntary, written informed consent to participate in this study
- Skeletal immaturity
- Female people who are pregnant or lactating
- Body mass index \> 30 kg/m2
- Malignancy
- Steroid therapy by systemic or intra-articular route within the last 60 days before informed consent or intramuscular or oral steroids within the last 30 days before informed consent
- Contraindications to MR imaging
- Drug addiction (including narcotic, anesthetic or alcohol addiction)
- Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder; taking anticoagulants except low dose aspirin
- Patients who are at higher risk for post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection)
- Known allergy to porcine/bovine collagen
- Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
- Patients with human immunodeficiency virus, hepatitis, or syphilis
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- Poor general health condition as judged by investigator
- Unable to do follow up
The study team makes the final eligibility decision.
Where it's taking place
- Jordon, Hong Kong
- Shatin, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jordon, Hong Kong; Shatin, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.