NCT01453829

Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients After Stroke

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Internal Carotid Artery and Intravenously in Patients After Stroke

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ageless Regenerative Institute · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients after Stroke and clinical outcomes?

Detailed description

Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from stroke. By injecting ASCs either into the internal carotid artery, these regions may become populated with the ASCs, thereby potentially restoring brain function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient into the internal carotid artery and intravenously. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.

Conditions

• Stroke

Interventions

Type	Name	Description
PROCEDURE	Harvesting and Isolation of Stem Cells	This will be an open-label, non-randomized multi-center patient sponsored study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be implanted into the Internal Carotid Artery and intravenously.

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2011-10-18
• Last updated: 2017-07-21

Locations

1 site across 1 country: Mexico