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

NCT01678534 | Completed Phase 2 DMC

• 2 other identifiers: AMASCIS-01/20112011-003551-18
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke

Keywords

Cerebral infarction; Cellular therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Efficacy

  3 months

• Efficacy

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

In patients randomly assigned to the placebo arm will receive a intravenous solution (containing the vehicle) with the same appearance as the drug under investigation. It will be administered as a single intravenous dose within the first two weeks after the onset of stroke symptoms.

Drug: Placebo

Allogeneic stem cells from adipose tissue

EXPERIMENTAL

The experimental drug is a solution of mesenchymal stem cells from adipose tissue. It will be administered as a single intravenous dose within the first two weeks after the onset of stroke symptoms.Dose: 1 million units/kg

Drug: Allogenic mesenchymal stem cells from adipose tissue

Interventions

Allogenic mesenchymal stem cells from adipose tissue DRUG

Allogeneic stem cells from adipose tissue

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

University Hospital La Paz

Madrid, 28046, Spain

Location

Related Publications (1)

• Diez-Tejedor E, Gutierrez-Fernandez M, Martinez-Sanchez P, Rodriguez-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 randomized, double-blind, placebo-controlled, single-center, pilot clinical trial. J Stroke Cerebrovasc Dis. 2014 Nov-Dec;23(10):2694-2700. doi: 10.1016/j.jstrokecerebrovasdis.2014.06.011. Epub 2014 Oct 7.

  PMID: 25304723 RESULT

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Infarction

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 5, 2012
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 28, 2018

Record last verified: 2017-12

Locations

ES (1)