Adipose Derived Cells for Chronic Obstructive Pulmonary Disease

NCT02041000 | Withdrawn

• 1 other identifier: ADI-US-COPD-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; pulmonary; stem cells; emphysema; lungs

Outcome Measures

Primary Outcomes (2)

• Safety

  Safety will be assessed as the occurrence/frequency (if applicable) of adverse events during the study procedures and for up to 6 months afterward.

  6 months

• St. George Respiratory

  The St. George Respiratory questionnaire is an index developed to identify the quality of life of patients by measuring and quantifying health-related health status of patients with airflow obstruction.

  6 months

Secondary Outcomes (2)

• Gold Classification

  6 months

• 6 Minute Walk Test

  6 months

Interventions

Adipose Derived Stem Cells OTHER

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioheart, Inc.: lead

Study Sites (1)

US Stem Cell Clinic

Sunrise, Florida, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristin Comella

  Bioheart

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

US (1)