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
| Verified date | January 2018 |
| Source | Banc de Sang i Teixits |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | May 2, 2017 |
| Est. primary completion date | May 2, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Patient between 40 and 60 years of age - Degenerative meniscus injury grade 3 (Crues et al.) - Indication of conservative treatment - Normal alignment of the knee (between 3º varus and 10 º valgus) - Patient is able to follow a rehabilitation program - Informed consent given by the patient in writing - Patient is able to understand the trial. Exclusion Criteria: - Traumatic meniscus injury - Surgical intervention to the affected knee - Local or systemic infection - Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months - Significant abnormal laboratory tests that contraindicates participation in the trial. - Pregnant women or intend to become pregnant or breast-feeding - Neoplastic process within the previous 5 years or without complete remission. - The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast. - Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria - Legally dependant patient. - The patient does not accept to be followed-up for a period that could exceed the clinical trial length |
| Country | Name | City | State |
|---|---|---|---|
| Spain | ICATME-Hospital Quiron Dexeus | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Banc de Sang i Teixits | Hospital Universitari Quirón Dexeus, Ministerio de Sanidad, Servicios Sociales e Igualdad |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | VAS for pain | Visual analogue scale (VAS) for pain at 12 month follow-up. | 12 month | |
| Secondary | Safety | Safety will be assessed by collecting adverse events, physical exam, laboratory tests, and vital signs. | 12 month | |
| Secondary | 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. | 6 and 12 month | |
| Secondary | VAS for pain | Visual analogue scale (VAS) for pain at 1, 3 and 6 month follow-up. | 1, 3 and 6 month | |
| Secondary | 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 |