Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial

Ischemic Stroke Clinical Trial

— AMASCIS-01  

Official title:

Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue. Safety Assessment. A Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial.(AMASCIS-01/2011)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678534
• Other study ID #: AMASCIS-01/2011
• Secondary ID: 2011-003551-18
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2012
• Last updated: February 27, 2018
• Start date: September 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind, placebo-controlled, with sequential inclusion of patients

Description:

20 Patients presenting with a moderate-severe acute ischemic stroke who will be randomized in a 1:1 proportion to intravenous treatment with allogeneic stem cells from adipose tissue or to placebo (vehicle).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion criteria:

• Male or female acute ischemic patients aged 60-80 years with symptoms of acute cerebral infarction of less than 12h from stroke onset. If the time of symptom onset is unknown, it shall refer to the last time the patient was asymptomatic seen.

• Patients should be treated within two weeks from the onset of stroke symptoms.

• Patients with a measurable focal neurological that must persist to the time of treatment without clinically meaningful improvement.

• Patients must have computerized tomography (CT) and / or magnetic resonance imaging (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory of the middle cerebral artery before being included in the study.

• Patients must have a score on the NIH Stroke Scale 8-20, with at least 2 of these points in Sections 5 and 6 (motor deficit) at the time of inclusion.

• Immediately (i.e. few minutes) before the stroke, patients should have a score on the mRS = 1 (no symptoms at all or no significant disability despite symptoms, able to perform everyday tasks and activities).

• Women of childbearing age should have a negative pregnancy test performed prior to inclusion.

• Obtaining informed consent signed (after a detailed explanation of the nature and purpose of this study, the patient or guardian or legal representative must give their consent to participate by signing the informed consent document). Assent from a relative or career if the patient is unable to give meaningful consent (e.g. in cases of dysphasia, confusion, or reduced conscious level).

Exclusion criteria:

• Comatose patients. Patients with a score of 2 or more in the item 1a of the NIHSS related to the degree of awareness.

• Evidence on neuroimaging (CT or MRI) of brain tumour, cerebral oedema with midline shift and clinically significant compression of ventricles, cerebellar infarction or brainstem, or intraventricular, intracerebral or subarachnoid haemorrhage.

• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.· Active infectious disease, including HIV, hepatitis B, Hepatitis C, etc.

• Pre-existing dementia.

• Specify health status or any clinical conditions (e.g., life expectancy, co-existing disease) or other characteristics that precludes appropriate diagnosis, treatment or follow-up in the trial.

• Patients who are participating in another clinical trial.

• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Allogenic mesenchymal stem cells from adipose tissue

• Placebo

Locations

Country	Name	City	State
Spain	University Hospital La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Díez-Tejedor E, Gutiérrez-Fernández M, Martínez-Sánchez P, Rodríguez-Frutos B, Ruiz-Ares G, Lara ML, Gimeno BF. Reparative therapy for acute ischemic stroke with allogeneic mesenchymal stem cells from adipose tissue: a safety assessment: a phase II random — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse events, complications.	To assess the safety of treatment with allogeneic stem cells from adipose tissue in acute ischemic stroke patients (Follow-up 24 months): Adverse events (AES) reported spontaneously or in response to questions not addressed. Serious adverse events. These will be recorded in each visit during all the study period (24 months).; Neurological and systemic complications: deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation, respiratory infections, urinary tract infections, deep venous thrombosis, pulmonary embolism, gastrointestinal haemorrhage… These will be recorded in each visit during all the study period (24 months).; Development of tumours	24 months
Secondary	Efficacy	To assess the potential efficacy of allogeneic stem cells from adipose tissue in acute ischemic stroke patients measured by the following parameters: Outcome at three months evaluated by: modified Rankin Scale and the NIH Stroke Scale; total volume of stroke by performing MRI. To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.	3 months
Secondary	Efficacy	To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.	3 months