EMIPLACEL for Knee osteoarthritis | Osteoarthritis

Inclusion criteria

• {"criterion_text":"- Signed written informed consent prior to initiation of any trial related measure."}
• {"criterion_text":"- Adult patients (f/m), 50 to 80 years old at the time of the screening visit"}
• {"criterion_text":"- Symptomatic mild to moderate OA of the index knee as defined by the OARSI-Joint Space Narrowing (JSN) Score of 1or 2 (standing Rosenberg AP x-ray)"}
• {"criterion_text":"- Pain in the index knee of 8-18 on the WOMAC pain score (reporting the last 48 hours, respectively at week 4 and week 1 before inclusion) after washout of at least 5 half-lives of previously taken NASAIDs medication(s)"}
• {"criterion_text":"- Failed conservative treatment, indicated by Pain in the index knee ≥ 3 months due to OA"}

Exclusion criteria

• {"criterion_text":"- Arthroscopy to the index knee within the last 12 months as well as surgery to other weight-bearing joints, that may interfere with index knee assessments"}
• {"criterion_text":"- Prior reconstructive cartilage transplantation or resurfacing procedures to the index knee"}
• {"criterion_text":"- Knee instability of clinical relevance such as lateral, medial or cruciate ligament instabilities that compromise patient during walking at time of screening"}
• {"criterion_text":"- Patients having received OA knee injection therapy (such as PRP, MSCs, or Hyaluronic Acid) in the last six months before screening"}
• {"criterion_text":"- Rheumatologic inflammatory arthropathies"}

Primary endpoints

• {"endpoint_text":"- Evaluation of the safety of the (PLX-PAD) cell treatment by assessing all adverse events, with specific consideration to allergic reactions, local site reactions, joint reactions, and immunosuppression. Adverse events shall be assessed for relatedness, seriousness and severity.","definition_or_measurement_approach":"Assessment of all adverse events with specific consideration to allergic reactions, local site reactions, joint reactions, and immunosuppression; AEs assessed for relatedness, seriousness and severity."}

Secondary endpoints

• {"endpoint_text":"- Primary Efficacy Endpoint: The potential change of the WOMAC pain score at week 26 compared to the baseline (BL) (visit 1) (0-20, where 0 is no pain).","definition_or_measurement_approach":"Change in WOMAC pain score from baseline to week 26 (scale 0-20)."}
• {"endpoint_text":"- Assessment of joint synovitis and effusion (MRI) at BL, weeks 26, 52 and 156;","definition_or_measurement_approach":"MRI assessment of joint synovitis and effusion at baseline, weeks 26, 52 and 156."}
• {"endpoint_text":"- Assessment of cartilage score using magnetic resonance imaging (MRI) location-independent analysis for knee articular cartilage at BL and weeks 52 and 156","definition_or_measurement_approach":"MRI-based cartilage scoring (location-independent analysis) at baseline and weeks 52 and 156."}
• {"endpoint_text":"- Assessment of WOMAC score at BL, weeks 1, 4, 12, 26, 52, 104, and 156","definition_or_measurement_approach":"WOMAC total/sections assessed at baseline and weeks 1,4,12,26,52,104,156."}
• {"endpoint_text":"- Assessment of the KOOS score at BL, weeks 1, 4, 12, 26, 52, 104, and 156","definition_or_measurement_approach":"KOOS assessed at baseline and weeks 1,4,12,26,52,104,156."}
• {"endpoint_text":"- Assessment of PROMIS-29 standardized QoL measure at BL, weeks 1, 4, 12, 26, 52, and 104","definition_or_measurement_approach":"PROMIS-29 quality-of-life instrument assessed at baseline and weeks 1,4,12,26,52,104."}
• {"endpoint_text":"- Exploratory Endpoint: evaluation of the use of pain medication at BL, weeks 1, 4, 12, 26, and 52","definition_or_measurement_approach":"Assessment of pain medication use recorded at baseline and weeks 1,4,12,26,52."}
• {"endpoint_text":"- Exploratory Endpoint: evaluation of the numeric pain rating scale (NPRS) at BL, weeks 1, 4, 12, 26, and 52","definition_or_measurement_approach":"NPRS measured at baseline and weeks 1,4,12,26,52."}
• {"endpoint_text":"- Exploratory Endpoint: evaluation of the NPRS after 10 Meter Walk Test at BL, weeks 26 and 52","definition_or_measurement_approach":"NPRS recorded immediately after 10 Meter Walk Test at baseline and weeks 26 and 52."}
• {"endpoint_text":"- Exploratory Endpoint: Genetic profile (Whole-genome sequencing, WGS)","definition_or_measurement_approach":"Whole-genome sequencing for genetic profiling (timing not specified)."}
• {"endpoint_text":"- Exploratory Endpoint: Biomarker analysis in synovial fluid (SF) specimens at BL and week 52","definition_or_measurement_approach":"Biomarker assays on synovial fluid at baseline and week 52."}
• {"endpoint_text":"- Exploratory Endpoint: Biomarker analysis in blood and urine specimens at BL and weeks 1, 4, 12, 26, and 52","definition_or_measurement_approach":"Biomarker assays in blood and urine at baseline and weeks 1,4,12,26,52."}
• {"endpoint_text":"- Exploratory Endpoint: Semiquantitative analysis of OA related degenerative alterations in the joint: MRI Osteoarthritis Knee Score (MOAKS) at BL, weeks 26, 52, and 156","definition_or_measurement_approach":"MOAKS semiquantitative MRI scoring at baseline and weeks 26,52,156."}
• {"endpoint_text":"- Exploratory Endpoint: Potential change from BL for extension strength for the ipsi- and contralateral knee at weeks 26 and 52","definition_or_measurement_approach":"Isokinetic or strength testing to assess extension strength change from baseline at weeks 26 and 52."}
• {"endpoint_text":"- Exploratory Endpoint: Functional 3D-gait analysis at BL and weeks 26 and 52","definition_or_measurement_approach":"3D gait analysis performed at baseline and weeks 26 and 52."}
• {"endpoint_text":"- Exploratory Endpoint:","definition_or_measurement_approach":""}

Other endpoints

• {"endpoint_text":"- Exploratory Endpoint: evaluation of the use of pain medication at BL, weeks 1, 4, 12, 26, and 52","definition_or_measurement_approach":"Assessment of pain medication use recorded at baseline and weeks 1,4,12,26,52."}
• {"endpoint_text":"- Exploratory Endpoint: evaluation of the numeric pain rating scale (NPRS) at BL, weeks 1, 4, 12, 26, and 52","definition_or_measurement_approach":"NPRS measured at baseline and weeks 1,4,12,26,52."}
• {"endpoint_text":"- Exploratory Endpoint: evaluation of the NPRS after 10 Meter Walk Test at BL, weeks 26 and 52","definition_or_measurement_approach":"NPRS recorded after 10 Meter Walk Test at baseline and weeks 26 and 52."}
• {"endpoint_text":"- Exploratory Endpoint: Genetic profile (Whole-genome sequencing, WGS)","definition_or_measurement_approach":"Whole-genome sequencing for genetic profiling."}
• {"endpoint_text":"- Exploratory Endpoint: Biomarker analysis in synovial fluid (SF) specimens at BL and week 52","definition_or_measurement_approach":"Synovial fluid biomarker analysis at baseline and week 52."}
• {"endpoint_text":"- Exploratory Endpoint: Biomarker analysis in blood and urine specimens at BL and weeks 1, 4, 12, 26, and 52","definition_or_measurement_approach":"Blood and urine biomarker analysis at baseline and specified follow-up weeks."}
• {"endpoint_text":"- Exploratory Endpoint: Semiquantitative analysis of OA related degenerative alterations in the joint: MRI Osteoarthritis Knee Score (MOAKS) at BL, weeks 26, 52, and 156","definition_or_measurement_approach":"MOAKS MRI assessment at baseline and weeks 26,52,156."}
• {"endpoint_text":"- Exploratory Endpoint: Potential change from BL for extension strength for the ipsi- and contralateral knee at weeks 26 and 52","definition_or_measurement_approach":"Extension strength testing at baseline and weeks 26 and 52."}
• {"endpoint_text":"- Exploratory Endpoint: Functional 3D-gait analysis at BL and weeks 26 and 52","definition_or_measurement_approach":"3D gait analysis at baseline and weeks 26 and 52."}
• {"endpoint_text":"- Exploratory Endpoint:","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

17-01-2024

Latest Decision Or Authorization Date

06-03-2024

Processing Time Days

49

Number Of Sites

1

Number Of Participants

132

Primary sponsor

Full Name

Charite Universitaetsmedizin Berlin KöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR","duties_or_roles":"sponsorDuties codes: 1,12,6,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Labor Berlin Charite Vivantes GmbH","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR (Augustenburger Platz address)","duties_or_roles":"Biomarker analysis; and code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR (Chariteplatz contact)","duties_or_roles":"3D gait analysis","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Finland","full_name":"University Of Oulu","duties_or_roles":"Biomarker analysis; and code 4","organisation_type":"Educational Institution"}
• {"country":"Austria","full_name":"Paracelsus Medizinische Privatuniversitaet Salzburg","duties_or_roles":"MRI assessment","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR (becat-gmp)","duties_or_roles":"Storage and delivery of the IMP to the trial site","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Biomarker analysis","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR (genetic profiling contact)","duties_or_roles":"Genetic profiling","organisation_type":"Hospital/Clinic/Other health care facility"}