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

NCT02216630 | Completed Phase 1

• 1 other identifier: KS-SVF-1002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

• 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

• Number of Adverse Events

  12 months

Secondary Outcomes (1)

• Secondary Efficacy Objective

  12 Months

Study Arms (1)

Adipose-Derived Stem Cell (ADSC) Therapy

EXPERIMENTAL

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

Interventions

Adipose Derived Stem Cell (ADSC) Therapy DRUG

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

Adipose-Derived Stem Cell (ADSC) Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85, inclusive
• A prior diagnosis of moderate to severe COPD
• GOLD IIa, III, IV

You may not qualify if:

• 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

Sponsors & Collaborators

• Kimera Society Inc: lead

Study Sites (5)

Melvin Propis M.D.

Davie, Florida, 33330, United States

Location

Chicago

Chicago, Illinois, 60061, United States

Location

Las Vegas

Las Vegas, Nevada, 89030, United States

Location

New York

New York, New York, 10001, United States

Location

Dallas

Dallas, Texas, 75251, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

US (5)