NCT01453777

Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Diffuse Lesions in the Brain

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Via Catheter Into the Internal Carotid Artery and Intravenously in Patients With Diffuse Lesions in the Brain

• Status: Withdrawn
• Phase: N/A
• 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 with diffuse brain lesions and clinical outcomes.

Detailed description

This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (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 delivered via catheter into the internal carotid artery and intravenously.

Conditions

• Brain Lesion (General)

Interventions

Type	Name	Description
PROCEDURE	harvesting and implantation of adipose derived stem cells	Adipose-Derived Stem cells will be derived from the patient's fat 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 delivered via catheter into the internal carotid artery and intravenously.

Timeline

• Start date: 2011-05-01
• 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