ischemic stroke MedDRA version: 16.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Células Mononucleares troncales adultas autólogas de médula ósea no expandidas
Product Code: CMMo
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Células Mononucleares
Sponsors
Iniciativa Andaluza en Terapias Avanzadas a través de la Fundación Progreso y Salud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes with age between 18 and 80 years old. 2. Clinical and radiological diagnosis of ischemiac stroke in the MCA (Middle Cerebral Artery) territory after 24 hours of beginning and with not more than 7 days after the appearance of the symptoms. 3. Radiological diagnosis of cerebral stroke and MCA's permeability by magnetic resonance/angio magnetic resonance (RM/aRM). 4. Scale of NIHSS's neurological deficit (National Institutes of Health Stroke Scale) of more than 6 points and up to 20. 5. Loss of strength of at least 2 points in motive articles in NIHSS except in the cases of aphasia. 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 76 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 76
Exclusion criteria
Exclusion criteria: 1. Disability or contraindication for the angiographic examination including the suspection in arterial dissection; 2.Hemorrhagic Ictus or stroke with hemorrhagic symptomatic transformation. 3. Patients with lacunar stroke. 4. Worsening in NIHSS's scale of 4 points or more in 24 hours before the treatment, attributable to edema and / or cerebral hemorrhage or suspectious in development of malignant stroke of middle cerebral artery. 5. Deficit in the Glasgow comma scale lower than 8 points; 6. Impossibility or contraindication for MR's acghivement; 7. Patients with malignant tumors, except basocelullar carcinoma 8. Punctuation in the modified Rankin scale previous to stroke equal or higher than 2. 9. Neurodegenerative diseases; 10. Unbalanced or acute cardiac insufficiency 11. Coexistence of any type of hematologic disease; 12. Contraindication for the puncture of bone marrow; 13. Clot related diseases 14. Hepatic insufficiency 15. Renal moderate insufficiency (creatinine higher of 2 mg / dl); 16. Concomitant serious diseases; 17. Pregnant women, in period of lactation, or in fertile age that they are not using a contraceptive effective method; 18. Patients who are currently enrolled or have been dismissed by a 3 months period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy in the intra-arterial infusion with mononuclear autologous bone marrow stem cells in patients with ischemic stroke, by the evaluation of the functional recovering after infusion;Secondary Objective: To validate the safety and feasibility, previously demonstrated clinic and experimentally, of the intra-arterial infusion of autologous bone marrow stem cells in patients with ischemic stroke acute and disabling neurological deficit, evaluating the possible appearance of adverse effects and toxicity derived from the treatment. To evaluate the changes produced after the treatment, with structurally neuroimagen (Magnetic Resonance), assessing the size of injured area as well as the perilesional atrophy. To confirm the modification in the serum levels of growth factors as the NGF (nerve growth factor). To evaluate the modifications induced in the cerebral perfusion by Cerebral Magnetic Resonance, after the above mentioned treatment. To confirm the relation observed in the previous study between the numbers of CD34 + infused and Barthel's index.;Primary end point(s): The main variable of the study will be the number of patients that reach the functional independence (scale modified of Rankin 0-2) after 6 months of the treatment;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary variables of efficiency: ?Improvement in the scale between the baseline period and 3 and 6 months, and between both groups, control and active arm. ? Independence in Barthel's scale (Barthel> 90). Between the baseline period and 3 and 6 months, and between both groups, control and active arm. ? Volume of stroke (diffusion in MR) - final volume of the stroke (FLAIR in MR) to 180 days between both groups, control and active arm. Secondary variables of efficiency: ? Mortality ?Tumorigenesis ?Cerebral hemorrhage ?Convulsions ? Record of vital signs (BP, HR), blood test (haemogram, ionogram, renal, biochemistry) and presence of complications related to the procedures of the trial (puncture of the hip iliac crest, catheterizations) besides the record of adverse events.;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Spain
Contacts
Public ContactAna Cardesa Gil
Iniciativa Andaluza en Terapias Avanzadas a través de la Fundación Progreso y Salud
Outcome results
None listed