Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163573
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-11-20
Brief Title:
Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Engineered Cartilage Implantation in a Randomized Controlled Multi-center Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this investigator-initiated study is to assess the efficacy of treating patellofemoral osteoarthritis with an Advanced Therapy Medicinal Product ATMP autologous nasal chondrocyte tissue engineered cartilage N-TEC in comparison with a standard therapy using platelet rich plasma injections
The engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type IIII membrane
The 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 phase II trial is to i evaluate the efficacy of autologous Nasal Chondrocytes Tissue Engineered Cartilage N-TEC in comparison to an active comparator Platelet Rich Plasma PRP injections based on patients self-assessed outcome scores Knee Osteoarthritis Outcome Score KOOS Pain and to ii verify tissue regeneration as the postulated mode of action and thus the disease-modifying properties of the graft as previously indicated in animal studies x-ray MRI This proposed phase II trial will evaluate whether N-TEC improves the clinical efficacy leading to an increase of at least 15 points higher in the main primary outcome KOOS pain change at 24 months than the comparator group Secondary endpoints will include amongst others KOOS subscales symptoms pain activity of daily living ADL sports Quality of Life QOL Kujala Anterior Knee Pain Scale Western Ontario and McMaster Universities Osteoarthritis score WOMAC Marx Activity Rating Scale MARS and EQ-5d assessment at 6 12 and 24 months compared to baseline and between groups Further secondary endpoints will be the number of subjects non-responding to treatment ie improvement in KOOS Pain below 13 units on a scale of 0-100 and treatment failures deterioration of more than 13 points compared to baseline or switching to other regenerative treatments or joint replacement to evaluate efficacy Adverse events will be recorded during the full course of the trial to assess safety This will require enrolling a total of 75 patients in a multicenter prospective study involving 9 clinical centers
The goal of this phase II trial is to i evaluate the efficacy of autologous Nasal Chondrocytes Tissue Engineered Cartilage N-TEC in comparison to an active comparator Platelet Rich Plasma PRP injections based on patients self-assessed outcome scores Knee Osteoarthritis Outcome Score KOOS Pain and to ii verify tissue regeneration as the postulated mode of action and thus the disease-modifying properties of the graft as previously indicated in animal studies x-ray MRI This proposed phase II trial will evaluate whether N-TEC improves the clinical efficacy leading to an increase of at least 15 points higher in the main primary outcome KOOS pain change at 24 months than the comparator group Secondary endpoints will include amongst others KOOS subscales symptoms pain activity of daily living ADL sports Quality of Life QOL Kujala Anterior Knee Pain Scale Western Ontario and McMaster Universities Osteoarthritis score WOMAC Marx Activity Rating Scale MARS and EQ-5d assessment at 6 12 and 24 months compared to baseline and between groups Further secondary endpoints will be the number of subjects non-responding to treatment ie improvement in KOOS Pain below 13 units on a scale of 0-100 and treatment failures deterioration of more than 13 points compared to baseline or switching to other regenerative treatments or joint replacement to evaluate efficacy Adverse events will be recorded during the full course of the trial to assess safety This will require enrolling a total of 75 patients in a multicenter prospective study involving 9 clinical centers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None