Degenerative meniscal lesion MedDRA version: 15.0 Level: PT Classification code 10069364 Term: Meniscal degeneration System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: XCEL-M-ALPHA
Product Code: XCEL-M-ALPHA
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Células mesenquimales autólogas
Current Sponsor code: XCE
Sponsors
Banc de Sang i Teixits
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient between 40 and 60 years of age 2. Degenerative meniscus infjury grade 3 (Crues et al.) 3. Indication of conservative treatment 4. Normal alignment of the knee (between 3º varus and 10 º valgus) 5.Patient is able to follow a rehabilitation program 6. Informed consent given by the patient in writing 7. Patient is able to understant the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Traumatic meniscus injury 2. Surgical intervention to the affected knee 3. Local or systemic infection 4. Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months 5. Significant abnormal laboratory tests that contraindicates participation in the trial. 6. Pregnant women or intend to become pregnant or breast-feeding 7. The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast. 8. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria 9. The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA by VAS for pain at 12 month follow-up.;Secondary Objective: - To assess the safety of intraarticular administration of XCEL-M-ALPHA in degenerative meniscus injury. - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA in degenerative meniscus injury by RM 1.5 Tesla at 6 and 12 month follow-up. - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA in cartilage injuries associated to degenerative meniscus injury by dGEMRIC and T2 mapping at 6 and 12 month follow-up. - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA by VAS for pain at 1, 3 and 6 month follow-up. - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA in degenerative meniscus injury by IKDC, KOOS and Lysholm functionality test and SF-36 quality of life at 3, 6 and 12 month follow-up.;Primary end point(s): Changes in pain score by VAS at 12 months follow up;Timepoint(s) of evaluation of this end point: At 12 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety: physical examination, vital signs, laboratory values and adverse events. -Imaging: - Qualitative and quantitative changes of the meniscus by magnetic resonance imaging 1.5 Tesla at 6 and 12 months. - Qualitative and quantitative changes in articular cartilage by T1 and T2 mapping at 6 and 12 months - Changes in pain score by VAS at 1, 3 and 6 months. - Changes in IKDC, KOOS and Lysholm tests at 3, 6, and 12 months. - Quality of life: changes in SF-36 at 3, 6, and 12 monts. - Histology in the event of knee surgery.;Timepoint(s) of evaluation of this end point: At 12 months follow-up | — |
Countries
Spain
Contacts
Public ContactRuth Coll
Banc de Sang i Teixits
Outcome results
None listed