NCT01501461

Study to Assess the Safety and Effects of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Intra-venous Implantation of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ageless Regenerative Institute · Industry
• Sex: All
• Age: 55 Years – 90 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 health of patients with human frailty syndrome.

Detailed description

This will be an open-label, non-randomized multi-center patient sponsored study of Autologous Adipose-Derived Stem Cells (ASC) implantation after liposuction using an IV 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 intravenously.

Conditions

• Frailty Syndrome

Interventions

Type	Name	Description
PROCEDURE	Harvesting and implantation of stem cells	The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for injection intravenously.

Timeline

• Start date: 2011-05-01
• Primary completion: 2017-05-30
• Completion: 2017-06-30
• First posted: 2011-12-29
• Last updated: 2018-04-19

Locations

1 site across 1 country: Mexico