Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.

Status Not yet recruiting

Clinical Trial 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 I/III membrane.

Clinical Trial 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 (i.e., 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06163573
Study type	Interventional
Source	University Hospital, Basel, Switzerland
Contact	Marcus Mumme, Dr
Phone	0041615565885
Email	marcus.mumme@usb.ch
Status	Not yet recruiting
Phase	Phase 2
Start date	April 2024
Completion date	September 2029

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT02825238` - Effect of Hip and Core Muscle Strengthening for Patellofemoral Osteoarthritis: A Feasibility Study	N/A
Completed	`NCT03281837` - 2 Weekly Intra-articular Hyaluronan Knee Injections, Given 1 wk. Apart, of HYMOVIS Combined With Physical Exercise Program (PEP) Compared to PEP Alone, in Relatively Young, Active Population of Subjects With Patellofemoral Osteoarthritis (PFOA) and/or Tibiofemoral Osteoarthritis (TFOA)	N/A
Completed	`NCT05184439` - Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.
Not yet recruiting	`NCT04332900` - Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic in People With Patellofemoral Osteoarthritis	N/A
Completed	`NCT02610192` - nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis	N/A
Completed	`NCT04589871` - Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis	N/A
Active, not recruiting	`NCT04817969` - Persona Ti-Nidium Post-Market Clinical Follow-up	N/A
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Terminated	`NCT00816647` - A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.