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

Phase 2

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Placebo; Drug: Allogenic mesenchymal stem cells from adipose tissue

• Registration Number: NCT01678534
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-05
• Study Start: 2014-09
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Allogeneic stem cells from adipose tissue	Allogenic mesenchymal stem cells from adipose tissue	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

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse events, complications.	24 months	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

Secondary Outcome Measures

Name	Time	Method
Efficacy	3 months	To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.

Trial Locations

Locations (1)

University Hospital La Paz; 🇪🇸 Madrid, Spain