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Not Yet Recruiting
NCT05751564
"Ready-to-use" Intra-articular Formulation of Mesenchymal Stromal Cells
Conditions: Osteo Arthritis Knee
Sex: All
Ages: 40 Years – 70 Years
Phase: PHASE2
Enrollment: 60
Sponsor: Universidad de los Andes, Chile
Summary
The goal of this clinical trial is to compare a newly developed off-the-shelf cryopreserved "ready to inject" Mesenchymal Stem Cell (MSC) product with the usual MSC preparation the investigators have used in knee osteoarthritis (OA) patients.
Since usual MSC therapy requires cell manipulation in GMP (Good Manufacturing Practices)-type facilities, this new formulation would enable wider access to Cell therapy and Multicentric clinical trials in areas devoid of expensive facilities and equipment.
Eligibility Criteria
Inclusion Criteria:Symptomatic knee OA defined by grade 1-3 Kellgren-Lawrence radiographic changes in the targeted knee.Daily pain at the affected joint for at least 3 months before inclusionExclusion Criteria:Bilateral symptomatic knee OA (only if the contralateral knee has more severe disease)Meniscal rupture.Condylar or tibial plateau generalized bone marrow edema on MRIMajor axial deviation defined by valgus (>10°) or varus (5°) deformity of the involved legUse of oral or intra-articular steroids or hyaluronic acid in the past 6 monthsIpsilateral hip or ankle pain, local or systemic infectionAny form of secondary arthritis, previous malignancy, or body mass index ≥30.
Source: ClinicalTrials.gov (NCT05751564). StuddyBuddy aggregates publicly available trial information.