The Clinical Outcome of BiCRI in the Treatment of Chondral and Osteochondral Lesions
NCT05924763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2025-09-25
Summary
Based on the previous successful experiences, the investigators like to extend our patient population. In this study, the investigators aim to determine the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) in the treatment of chondral and osteochondral lesions of the knee, including but not limited to more than one (1) lesion and the lesion that had been treated with microfracture or mosaicplasty but failed.
Conditions
- Articular Cartilage Disorder of Knee
Interventions
- DEVICE
-
Biphasic Cartilage Repair Implant (BiCRI)
The Biphasic Cartilage Repair Implant (BiCRI) is a two-phase scaffold composed of poly(lactic-co-glycolic acid) (PLGA) and β-triCalcium phosphate (TCP).
Sponsors & Collaborators
-
BioGend Therapeutics Co.Ltd
lead INDUSTRY
Principal Investigators
-
Gwen Chang · BioGend Therapeutics Co.Ltd
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-20
- Primary Completion
- 2022-06-10
- Completion
- 2022-08-18
Countries
- Taiwan
Study Locations
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