NCT04280003

Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke

Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke. A Phase IIB Multicenter Double Blind Placebo Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ischemic Stroke
• Adipose Tissue-derived Stem Cell
• Functional Status

Interventions

Type	Name	Description
OTHER	Alogenic adipose tissue-derived stem cells	Concentration of the cells: 10 million cells / ml
DRUG	Placebo solution	Placebo intravenous solution, same appearance stem cells solution

Timeline

• Start date: 2021-01-20
• Primary completion: 2023-07-15
• Completion: 2023-07-15
• First posted: 2020-02-21
• Last updated: 2023-05-30

Locations

1 site across 1 country: Spain