Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576583
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Multi-center Phase II Clinical Trial for the Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Tissue Engineered Cartilage Implantation vs Current Standard of Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENCANTO
Brief Summary:
ENCANTO is a randomized controlled multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis PFOA with an Advanced Therapy Medicinal Product ATMP nasal chondrocyte-based tissue engineered cartilage N-TEC implantation in comparison with current standard of care depending on the stage of osteoarthritis The goal of this phase II trial is to evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis AMIC for early stage PFOA or patellofemoral arthroplasty PFA for late stage PFOA
The N-TEC engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type IIII membrane
The N-TEC engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type IIII membrane
Detailed Description:
Knee osteoarthritis OA is one of the most common causes for pain and disability with over 260 million people affected worldwide Recent studies found that knee OA often starts in the patello-femoral compartment of the knee PFOA and is diagnosed in 39 of people with knee pain aged above 30 years Thus PFOA and progression to full OA plays a crucial role in the reduction of quality of life of many people and in the raise of healthcare costs
The goal of this multi-center phase II trial is to i evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis AMIC for early stage PFOA or patellofemoral arthroplasty PFA for late stage PFOA based on patient self-assessed questionnaires Knee Injury and Osteoarthritis Outcome Score KOOS and ii verify the postulated mode of action which is expected to be of regenerative nature and will be assessed by evaluation of disease-modification by x- ray and structural regeneration of the osteoarthritic joint destruction by MRI analysis A total of 150 patients with early stage of PFOA Iwano grade 1-2 75 patients or late stage of PFOA Iwano grade 3-4 75 patients will be enrolled in 11 clinical centers and randomized to either N-TEC implantation or active comparator AMIC or PFA
The goal of this multi-center phase II trial is to i evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis AMIC for early stage PFOA or patellofemoral arthroplasty PFA for late stage PFOA based on patient self-assessed questionnaires Knee Injury and Osteoarthritis Outcome Score KOOS and ii verify the postulated mode of action which is expected to be of regenerative nature and will be assessed by evaluation of disease-modification by x- ray and structural regeneration of the osteoarthritic joint destruction by MRI analysis A total of 150 patients with early stage of PFOA Iwano grade 1-2 75 patients or late stage of PFOA Iwano grade 3-4 75 patients will be enrolled in 11 clinical centers and randomized to either N-TEC implantation or active comparator AMIC or PFA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None