Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue

Last updated: May 2, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

eOCT implantation

Clinical Study ID

NCT06400862
eOCT
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: Subjects 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 (Asdiagnosed by MRI)
  • Conservative treatments failed (for > 4 months)

Exclusion

Exclusion Criteria: 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 3months 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 thetarget 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---
  • Subjects who are not able or not willing to give voluntary, written informed consentto participate in this study
  • Skeletal immaturity
  • Female subjects 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 beforeinformed consent or intramuscular or oral steroids within the last 30 days beforeinformed 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., takingimmunosuppressants; 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 thatwould 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 lowerextremities
  • Poor general health condition as judged by investigator
  • Unable to do follow up

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: eOCT implantation
Phase: 1
Study Start date:
February 26, 2024
Estimated Completion Date:
December 31, 2026

Study Description

TCL-aMSC- eOCT is a single arm first-in-human trial designed to establish the safety profile of autologous tissue engineered osteochondral tissue (eOCT) in patients with traumatic chondral lesions. Patient selection will base on medical records, especially MRI results, and other criteria. Patient enrollment and informed consent will be conducted at the baseline visit. In a pre-treatment visit, bone marrow aspiration will be conducted to harvest autologous bone marrow for mesenchymal stem/stromal cells (MSCs) isolation and subsequent eOCT manufacturing. Cartilage lesion will be repaired in the treatment visit by delivering eOCT through arthroscopic surgery roughly 13 weeks after the pre-treatment visit. Rehabilitation will be conducted post-implantation. Multiple follow-up visits will be conducted up to 24 months post-implantation, data including adverse events, clinical and functional scoring and blood tests will be collected during each follow-up visit. Radiological assessment such as magnetic resonance imaging (MRI) will be conducted regularly until the end of the study.

Connect with a study center

  • Queen Elizabeth Hospital

    Jordon,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital

    Sha Tin,
    Hong Kong

    Active - Recruiting

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