Patients aged 18 to 65 years with symptomatic chondral defects classified as International Cartilage Repair Society (ICRS) grade 3 or 4 that require surgical intervention. cartilage lesion stem cells chondrogenic induction regenerative medicine joint pain joint regeneration orthoregeneration
Conditions
Interventions
EpiBone'
s injectable articular cartilage (EB-iAC) is a biologically similar tissue material developed through the use of allogenic bone marrow derived mesenchymal stromal cells (BM-MSCs). The cells are proces
s natural physiological development by inducing BM-MSCs to form cartilage precursor tissue through mesenchymal condensation to generate drug substance EB-CMB. Upon implantation, EB-iAC is anticipated
Experimental Biological/Vaccine
EB-iAC
Sponsors
EpiBone Inc
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subject is male or female, between 18 and 65 years of age 2. Subject's body mass index (BMI) is less than or equal to 35 kg/m2 3. Subject has up to two symptomatic, cartilage defects that are: 3a. Each between 0.5 and 4 cm2 in area on screening images 3b. Classified as International Cartilage Repair Society (ICRS) grade 3 or 4 3c. Cartilage defect is in either knee or ankle 4. Subject is willing and able to provide informed consent and comply with study requirements. 5. Subject agrees to actively participate in a strict rehabilitation protocol and follow-up program. 6. For female of childbearing potential, subject must have a negative urine pregnancy test at Screening, cannot be lactating and must be willing to use adequate contraception throughout study participation. 7. Subject is willing to give up the use of narcotics for 6 months post-surgery and use and record alternative pain medications (OTC or prescribed).
Exclusion criteria
Exclusion criteria: 1. Lesions on the opposing surface that are classified as ICRS grade 4. 2. Lesions on the opposing surface of the patella that are classified as ICRS grade 4 if a trochlear defect is being treated. 3. Any existing prosthetic implants in the index joint. 4. History of surgery in the index joint within 6 months prior to screening. 5. Has osteoarthritis of Kellgren-Lawrence Grade greater than or equal to 3 as diagnosed on standing radiographs in the index joint. 6. Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. 7. Current infection or history of infection in the index joint. 8. Current skin infection of the index joint or skin infection of the index joint within the past 3 months. 9. Avascular necrosis (AVN) or osteonecrosis (ON). 10. If treating knee joint, meniscus tears or defects that require concomitant or prior removal of >50% of meniscus in the index joint. 11. If treating knee joint, varus or valgus malalignment exceeding 5 degree in either knee. 12. If treating knee joint, need for corrective concomitant osteotomy (tibio-femoral or patellofemoral). 13. Symptomatic musculoskeletal condition in the lower limbs that could impede efficacy measures in the target knee. 14. Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal if not on long term remission (e.g., at least 5 years or negative biopsy at last exam), except basal cell carcinoma. 15. Clinically significant abnormalities in vital signs at the time of screening defined by: 15a. Resting Pulse <60 or >100 bpm 15b. Respiratory Rate <9 or >20 15c. Temperature >37.8 degree celcius 16. Hemoglobin, platelet, white blood cell count, creatinine, aspartate aminotransferase (AST), and alanine aminotransferase (ALT), prothrombin time (PT), and partial thromboplastin time (PTT) below the lower limit of normal or above the upper limit of normal. 17. Active bacterial infection 18. Alcohol and drug (including medication) abuse. 19. Subjects with any contraindications to MR imaging. 20. Participation in concurrent trials or in previous trials within 90 days of signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incident of adverse events within 1 year of intervention Not statistical method,Incident of adverse events severity within 1 year of intervention Not statistical method,Incident of secondary surgical interventions within 1 year of intervention Not statistical method | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in pain within 1 year of intervention Visual analog scale (VAS) pain intensity score (0-10),Pain and Function 5 weeks, 3, 6, and 12 months Scoring metric: KOOS and IKDC for knee , FAOS for ankle (0-100),Cartilage regeneration 6 and 12 months MRI AMADEUS score (0-100),Cartilage regeneration 6 and 12 months MRI MOCART score (0-100) | — |
Countries
Thailand
Contacts
Public ContactSuchittra Puttawong
Clinixir Company Limited
Outcome results
None listed