Osteoarthritis, Knee Clinical Trial
Official title:
Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.
This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15
patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the
study with the primary objective of assessing the feasibility and safety of the knee
articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary
objectives are to assess the efficacy by imaging procedures and clinical questionnaires.
MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under
GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21
days, patients will be implanted a single-dose of approximately 40 millions of autologous
MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage
changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical
assessment will measure the pain by the visual analogue scale (VAS), the self-reported
functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short
Form 36 questionnaire (SF-36) at 3, 6 and 12 month.
The working hypothesis proposes that the expected regenerative articular cartilage effect of
the MSC will be produced to a measurable degree by imaging procedures and clinical
questionnaires.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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