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

Kimera Society Inc26 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Adipose Derived Stem Cell (ADSC) TherapyDRUG

Patients undergo a liposuction where 100 cc of fat are extracted. The ADSCs are then isolated and injected intravenously.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (5)

Melvin Propis M.D.

Davie, Florida, United States

Chicago

Chicago, Illinois, United States

Las Vegas

Las Vegas, Nevada, United States

New York

New York, New York, United States

Dallas

Outcomes

Primary Outcomes

FEV1 Decline

The primary efficacy outcome will be a FEV1 decline of approximately or less than 30 ml at 12 month follow-up.

Time frame: 12 months

Number of Adverse Events

Time frame: 12 months

Secondary Outcomes

Secondary Efficacy Objective

The secondary efficacy objective will be a decrease in six minute walking distance (6MWD) of less than 5% over one year.

Time frame: 12 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.