Alogenic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke (AMASCIS-02)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04280003|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Instituto de Investigación Hospital Universitario La Paz
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
This is a multicenter, doble blind, placebo controlled clinical trial to asses de safety and efficacy of intravenous administration of alogenic adipose tissue-derived mesenchymal stem cells in the first four days from acute ischemic stroke.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Adipose Tissue-derived Stem Cell Functional Status||Other: Alogenic adipose tissue-derived stem cells Drug: Placebo solution||Phase 2|
Two spanish hospitals with teams experienced in stroke management will participate in this study, recruiting a total of 30 patients between them both. After confirming that patients fulfill the inclusion criteria and none of the exclusion criteria, informed consent will be signed and randomization will take place (1:1). There are two different groups of treatment; the first group will be treated with intravenous alogenic adipose tissue-derived stem cells (at a concentration of one million cells per kg) within the first four days from stroke onset, the second group will be treated will an intravenous placebo solution. Follow-up will last for 24 months during which safety issues such as adverse events and neurological and systemic complications will be assessed at 24 hours, 7 days and 3, 6, 12,18 and 24 months after treatment. Neurological disability using the modified Rankin Scale and National Institute of Health Stroke Scale will also be registered in every scheduled visit. Biochemical markers of tissue repair (GM-CSF, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3) as well as extracellular vesicles will be extracted on baseline visit as well as 7 days and 3 months after treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two different treatment grupos; intravenous alogenic adipose tissue-derived mesenchymal stem cells or intravenous placebo solution|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Treatment and placebo solutions have identical appearance. Protocols will be designed to ensure that the physician evaluating patient safety and efficacy outcome as well as laboratory analysis, will not have access to the randomisation codes.|
|Official Title:||Alogenic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke. A Phase IIB Multicenter Double Blind Placebo Controlled Clinical Trial|
|Estimated Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||May 1, 2023|
Experimental: Treatment group
15 patients will receive intravenous alogenic adipose tissue-derived stem cells in a single dose of one million cells per kg.
Other: Alogenic adipose tissue-derived stem cells
Concentration of the cells: 10 million cells / ml
Placebo Comparator: Placebo group
15 patients will receive a single intravenous placebo solution with the same appearance as the treatment group.
Drug: Placebo solution
Placebo intravenous solution, same appearance stem cells solution
Primary Outcome Measures :
- Safety of administration of adipose tissue-derived mesenchymal stem cells measured as reported adverse events [ Time Frame: Up to 24 months after treatment or placebo administration ]Adverse events reported spontaneously or in response to questions not addressed.
- Safety of administration of adipose tissue-derived mesenchymal stem cells measured as neurological o systemic complications [ Time Frame: Up to 24 months after treatment or placebo administration ]Neurological or systemic complications
Secondary Outcome Measures :
- Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the Modified Rankin Scale [ Time Frame: Up to 24 months after treatment or placebo administration ]Modified Rankin Scale (mRS): success is considered when the patient obtains a score of 0-3, and failure include scores of 4 to 6 at months 3,6,12 and 24. An additional exploratorry efficacy analysis of mRS shift at months 3,6,12 and 24 will also be made.
- Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the NIHSS [ Time Frame: Up to 24 months after treatment or placebo administration ]National Institute of Health Stroke Scale. It will be measured at all scheluded visits. Success is defined as an improvement of 75% or more from baseline. An additional exploratory analysis will look for differences in the distribution of median 8IQR) and in the frequency of NIHSS ≤ 1between groups.
- Efficacy of administration of adipose tissue-derived mesenchymal stem cells measuring blood brain repair biomarkers [ Time Frame: Up to 3 months after treatment or placebo administration ]Brain repair biomarkers in blood samples (GM-CSF, PDGF-BB, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3 and extracelular vesicles) measured at baseline, day 7 and mnth 3 after treatment or placebo administration.
No Contacts or Locations Provided