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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

An Open-label, Non-Randomized, Multi-center Study to Assess the Safety and Effects of Intravenous Implantation of Liposuction Derived Autologous Adipose-derived Stem Cells in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216630
• Other study ID #: KS-SVF-1002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 7, 2014
• Last updated: July 22, 2017
• Start date: August 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Kimera Society Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be an open-label, non-randomized multi-center study designed to assess the safety and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Description:

In the context of the proposed study, adipose derived stem cells (ASC) constitute an autologous cell product that is delivered to the patient via intra-venous injection. In this study, we propose to investigate the immunosuppressive potential of the non-manipulated non-cultured stromal vascular fraction obtained via liposuction. Endpoints will be measured both by improvement of the forced evacuation volume in one second (FEV1) and distance covered in a 6 minute walk distance test (6MWD). The stromal vascular fraction comprises stromal cells isolated from total fat via enzymatic digestion ex-vivo. These cells are not cultured but are isolated from adipose tissue using a sterile tissue process in under two hours. The process includes rinsing in a saline solution to remove red blood cells, draining, and enzymatic digestion (collagenase) which isolates endothelial cells from adipose tissue. Post-processing, the pellet obtained via centrifugation is filtered and delivered to the patient who remains sedated within the same ambulatory center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 18 to 85, inclusive

• A prior diagnosis of moderate to severe COPD

• GOLD IIa, III, IV

Exclusion Criteria:

• Pregnant or lactating

• Life expectancy < 6 months due to concomitant illnesses.

• Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.

• Any illness which, in the Investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results

• Subjects on chronic immunosuppressive or chemotherapeutic therapy

• Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.

• Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease).

• Unwilling and/or not able to give written consent

• Patient is positive for hepatitis (past history of Hepatitis A is allowed)

• Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient

• Cerebral aneurysm clips

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Adipose Derived Stem Cell (ADSC) Therapy
Patients undergo a liposuction where 100 cc of fat are extracted. The ADSCs are then isolated and injected intravenously.

Locations

Country	Name	City	State
United States	Chicago	Chicago	Illinois
United States	Dallas	Dallas	Texas
United States	Melvin Propis M.D.	Davie	Florida
United States	Las Vegas	Las Vegas	Nevada
United States	New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Kimera Society Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 Decline	The primary efficacy outcome will be a FEV1 decline of approximately or less than 30 ml at 12 month follow-up.	12 months
Primary	Number of Adverse Events		12 months
Secondary	Secondary Efficacy Objective	The secondary efficacy objective will be a decrease in six minute walking distance (6MWD) of less than 5% over one year.	12 Months