Adipose Derived Cells for Chronic Obstructive Pulmonary Disease

NCT ID: NCT02041000

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31

Brief 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 disease pathology of patients with diagnosed with chronic obstructive pulmonary disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Adipose Derived Stem Cells

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• A prior diagnosis of moderate or severe COPD
• GOLD III and IV
• Age between 18 and 85 years

Exclusion Criteria

• Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
• 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.
• Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
• Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
• Patients on chronic immunosuppressive transplant 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.
• Severe asthma that would contraindicate surgery
• History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
• Patients with Alpha-1
• Unwilling and/or not able to give written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioheart, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Comella

Role: STUDY_DIRECTOR

Bioheart

Locations

US Stem Cell Clinic

Sunrise, Florida, United States

Countries

United States

Other Identifiers

ADI-US-COPD-001

Identifier Type: -

Identifier Source: org_study_id