Mesenchymal Stromal Cells for Degenerative Meniscus Injury
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|ClinicalTrials.gov Identifier: NCT02033525|
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Meniscal Injury||Drug: XCEL-M-ALPHA and standard rehabilitation Other: Rehabilitation||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury|
|Actual Study Start Date :||January 31, 2014|
|Actual Primary Completion Date :||May 2, 2017|
|Actual Study Completion Date :||May 2, 2017|
Experimental: XCEL-M-ALPHA and standard rehabilitation
Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program
Drug: XCEL-M-ALPHA and standard rehabilitation
Intraarticular infusion of autologous bone marrow derived ex vivo expanded mesenchymal stromal cells produced at Xcelia (Advanced Therapies Division of the Blood and Tissue Bank)
Other Name: XCEL-M-ALPHA
Active Comparator: standard rehabilitation
Standard rehabilitation program
Standard rehabilitation program
- VAS for pain [ Time Frame: 12 month ]Visual analogue scale (VAS) for pain at 12 month follow-up.
- Safety [ Time Frame: 12 month ]Safety will be assessed by collecting adverse events, physical exam, laboratory tests, and vital signs.
- Efficacy by MRI [ Time Frame: 6 and 12 month ]Efficacy will be assessed by qualitative and quantitative changes of the meniscus and articular cartilage by imaging procedures (MRI) at 6 and 12 month follow-up.
- VAS for pain [ Time Frame: 1, 3 and 6 month ]Visual analogue scale (VAS) for pain at 1, 3 and 6 month follow-up.
- Efficacy by clinical questionnaires [ Time Frame: 3, 6 and 12 month ]IKDC, KOOS and Lysholm functionality test and SF-36 quality of life at 3, 6 and 12 month follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033525
|ICATME-Hospital Quiron Dexeus|
|Barcelona, Spain, 08028|
|Principal Investigator:||Joan Carles Monllau, MD, PhD||ICATME-Hospital Quiron Dexeus|