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Adipose Derived Cells for Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adipose Derived Stem Cells

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, pulmonary, stem cells, emphysema, lungs

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

US Stem Cell Clinic

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Gold Classification

The GOLD COPD staging system classifies people with COPD based on their degree of airflow limitation (obstruction). The airflow limitation is measured during pulmonary function tests

6 Minute Walk Test

Exercise capacity as measured as the distance a patient can walk over a 6 minute time period.

Full Information

NCT ID

NCT02041000

First Posted

January 17, 2014

Last Updated

March 15, 2017

Sponsor

Bioheart, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02041000

Brief Title

Adipose Derived Cells for Chronic Obstructive Pulmonary Disease

Official Title

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Withdrawn

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioheart, Inc.

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, pulmonary, stem cells, emphysema, lungs

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Adipose Derived Stem Cells

Primary Outcome Measure Information:

Title

Safety

Description

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

Time Frame

6 months

Title

St. George Respiratory

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Gold Classification

Description

The GOLD COPD staging system classifies people with COPD based on their degree of airflow limitation (obstruction). The airflow limitation is measured during pulmonary function tests

Time Frame

6 months

Title

6 Minute Walk Test

Description

Exercise capacity as measured as the distance a patient can walk over a 6 minute time period.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristin Comella

Organizational Affiliation

Bioheart

Official's Role

Study Director

Facility Information:

Facility Name

US Stem Cell Clinic

City

Sunrise

State/Province

Florida

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Adipose Derived Cells for Chronic Obstructive Pulmonary Disease

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