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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006270-13 | EudraCT Number |
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| Name | Class |
|---|---|
| Hospital Universitari Quirón Dexeus | UNKNOWN |
| Ministerio de Sanidad, Servicios Sociales e Igualdad | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XCEL-M-ALPHA and standard rehabilitation | Experimental | Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program |
|
| standard rehabilitation | Active Comparator | Standard rehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XCEL-M-ALPHA and standard rehabilitation | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| VAS for pain | Visual analogue scale (VAS) for pain at 12 month follow-up. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety will be assessed by collecting adverse events, physical exam, laboratory tests, and vital signs. | 12 month |
| Efficacy by MRI | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Carles Monllau, MD, PhD | ICATME-Hospital Quiron Dexeus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICATME-Hospital Quiron Dexeus | Barcelona | 08028 | Spain |
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| Label | URL |
|---|---|
| Fundación ICATME (Spanish only) | View source |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Rehabilitation | Other | Standard rehabilitation program |
|
| 6 and 12 month |
| VAS for pain | Visual analogue scale (VAS) for pain at 1, 3 and 6 month follow-up. | 1, 3 and 6 month |
| Efficacy by clinical questionnaires | IKDC, KOOS and Lysholm functionality test and SF-36 quality of life at 3, 6 and 12 month follow-up | 3, 6 and 12 month |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |