Actively Recruiting
Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue
Led by Chinese University of Hong Kong · Updated on 2024-05-06
9
Participants Needed
2
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Single symptomatic cartilage defect on medial or lateral femoral condyle
- Contained single focal cartilage lesion approximately 1-4 cm squared
- Cartilage damage graded as ICRS/Outerbridge grade III or IV reaching subchondral bone confirmed by MRI
- Failure of conservative treatments for more than 4 months
You will not qualify if you...
- Previous cartilage repair surgery (OATS or ACI/MACI) in the affected knee
- Injection treatments such as HA, PRP, or stem cells in the affected knee within 3 months before consent
- Clinically relevant patellofemoral cartilage lesion in the affected knee
- Inflammatory joint diseases including specific or non-specific arthritis
- Metabolic diseases such as gout or rheumatism
- Advanced osteoarthritis with Kellgren & Lawrence grade greater than 2
- Osteochondritis dissecans
- Multiple or uncontained cartilage lesions detected by MRI or arthroscopy
- Uncorrected ligament deficiency
- Uncorrected varus or valgus malalignment exceeding 5 degrees
- Ongoing infection or skin disease at the target knee
- Significant meniscal loss
- Unable or unwilling to provide written informed consent
- Skeletal immaturity
- Pregnant or lactating females
- Body mass index over 30 kg/m2
- Malignancy
- Recent steroid therapy within 30 to 60 days before consent depending on route
- Contraindications to MRI
- Drug addiction including narcotics, anesthetics, or alcohol
- High risk for post-surgical bleeding or infection
- Allergy to porcine or bovine collagen
- Painful or disabling diseases of spine, hips, or lower limbs affecting knee evaluation
- Infections such as HIV, hepatitis, or syphilis
- Significant vascular or neurologic disorders of lower extremities
- Poor general health as judged by investigator
- Inability to complete follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Queen Elizabeth Hospital
Jordon, Hong Kong
Actively Recruiting
2
Prince of Wales Hospital
Shatin, Hong Kong
Actively Recruiting
Research Team
B
Barbara Pui CHAN, PhD
CONTACT
Y
Yinan QIU, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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