NCT01559051

Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Intra-venous and Inhalation Implantation of Autologous Adipose-Derived Stromal Vascular Fraction Cells in Patients With Chronic Obstructive Pulmonary Disease

• Status: Withdrawn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 and 2) Is treatment effective in improving the health of patients with human Chronic Obstructive Pulmonary Disease.

Detailed description

This will be an open-label, non-randomized multi-center patient sponsored study of Autologous SVF (AD-SVF) implantation after liposuction using an IV delivery system and Inhalation infusion. AD-SVF 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. 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 IV delivery. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
PROCEDURE	Lipoaspiration with Local anesthesia	Patients undergo a liposuction under local Anethesia. The AD-SVF are then isolated and infused IV and by inhalation delivery.

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-11-01
• Completion: 2017-12-01
• First posted: 2012-03-21
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States