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 Intravenous Implantation of Liposuction Derived Autologous Adipose-derived Stem Cells in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Adipose Derived Stem Cell (ADSC) Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Davie, Florida, United States, 33330
      • Melvin Propis M.D.
  • Illinois
    • Chicago, Illinois, United States, 60061
      • Chicago
  • Nevada
    • Las Vegas, Nevada, United States, 89030
      • Las Vegas
  • New York
    • New York, New York, United States, 10001
      • New York
  • Texas
    • Dallas, Texas, United States, 75251
      • Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adipose-Derived Stem Cell (ADSC) Therapy; This arm, as the sole arm, will consist of the ADSC treatment procedure. Intervention will consist of Adipose Derived Stem Cell (ADSC) Therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events		12 months
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kimera Society Inc

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 22, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: KS-SVF-1002