A phase I/IIa, prospective, mono-center, double-blinded, randomized, controlled study to assess the safety and efficacy of applying PLX-PAD cells for the treatment of mild to moderate knee osteoarthritis - PROTO

Phase 1

Active, not recruiting

• Conditions: Osteoarthritis; MedDRA version: 21.1Level: LLTClassification code: 10023476Term: Knee osteoarthritis Class: 10028395; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2023-504212-15-00
• Lead Sponsor: Charite Universitaetsmedizin Berlin KöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Signed written informed consent prior to initiation of any trial related measure., Adult patients (f/m), 50 to 80 years old at the time of the screening visit, 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), 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), Failed conservative treatment, indicated by Pain in the index knee = 3 months due to OA

Exclusion Criteria

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, Prior reconstructive cartilage transplantation or resurfacing procedures to the index knee, Knee instability of clinical relevance such as lateral, medial or cruciate ligament instabilities that compromise patient during walking at time of screening, Patients having received OA knee injection therapy (such as PRP, MSCs, or Hyaluronic Acid) in the last six months before screening, Rheumatologic inflammatory arthropathies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified