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

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт eOCT implantation
  eOCT is regarded as an Advanced Therapy Product (ATP).

Первичные конечные точки

• Safety Outcomes [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]

Вторичные конечные точки (9)

• Visual Analogue Scale (VAS) [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]
• The Western Ontario and McMaster University Osteoarthritis index (WOMAC) [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]
• World Health Organization Quality of Life Instruments (WHOQOL-BREF) [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]
• Short-Form- 36 (SF-36) [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]
• Kellgren and Lawrence (K&L) grading [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]
• Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score 2.0 [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]
• T2 mapping signal [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]
• Cartilage thickness [Срок оценки: From subject enrollment to 24 months after the eOCT implantation.]

Критерии участия

Критерии включения

• 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 (As diagnosed by MRI)
• Conservative treatments failed (for > 4 months)

Критерии исключения

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---

• Subjects who are not able or not willing to give voluntary, written informed consent to 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 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 2 центра

• Queen Elizabeth Hospital — Jordon
• Prince of Wales Hospital — Shatin

Идентификаторы

NCT: NCT06400862 · eOCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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