Chronic Meniscal Injury Clinical Trial
Official title:
A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury
The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.
This is a prospective, unicentric, randomized, open-label, single-dose, two-arm, blinded
assessor pilot study in which 20 patients with degenerative meniscus injury grade 3 (Crues et
al.) will enter the study with the primary objective of assessing the efficacy of the
treatment by VAS of pain at 12 month. Secondary objectives are to evaluate the safety and
efficacy through imaging procedures and clinical questionnaires (IKDC, KOOS, Lysholm and
SF-36.
Patients will be randomized to one of the two treatment arms (XCEL-M-ALPHA and standard
rehabilitation program or standard rehabilitation program alone). Thereafter, patients will
be followed for 12 months.
Imaging assessment will be performed by an independent blinded radiologist.
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