NCT01453803

Study to Assess the Safety and Effects of Autologous Adipose-Derived SVF Cells in Patients With Parkinson's Disease

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously and Intranasally in Patients With Parkinson's Disease

• Status: Withdrawn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 Parkinson's Disease 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 Vertebral Artery and intravenously.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
PROCEDURE	Harvesting and Implantation of Adipose-Derived Stem Cells	The adipose tissue specimen will be collected from the patient's abdomen or applicable region using a liposuction cannula. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for catheter injection.

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-11-01
• Completion: 2017-12-01
• First posted: 2011-10-18
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States