Chronic Obstructive Pulmonary DiseaseNCT02041000
Adipose Derived Cells for Chronic Obstructive Pulmonary Disease
A study testing Adipose Derived Stem Cells in people with Chronic Obstructive Pulmonary Disease, run by Bioheart, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Adipose Derived Stem Cells
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A prior diagnosis of moderate or severe COPD
- GOLD III and IV
- Age between 18 and 85 years
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Adipose Derived Stem Cells
- Keywords
- COPD, pulmonary, stem cells, emphysema, lungs
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Derived Stem CellsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
6 Minute Walk Test
Exercise capacity as measured as the distance a patient can walk over a 6 minute time period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioheart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Comella, Study director, Bioheart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041000
- Sponsor's protocol ID
- ADI-US-COPD-001
- Status last verified
- Mar 2017
- First submitted
- 17 Jan 2014
- Last updated
- 16 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02041000
- Acronym / sponsor ID
- ADI-US-COPD-001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, pulmonary, stem cells, emphysema, lungs
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bioheart, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2017 (estimated)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A prior diagnosis of moderate or severe COPD
- GOLD III and IV
- Age between 18 and 85 years
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose Derived Stem Cells | Other | – |
Primary outcome
Safety
Time frame: 6 months
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
Time frame: 6 months
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.
2 secondary outcomes
Gold Classification
Time frame: 6 months
6 Minute Walk Test
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Comella study director
Bioheart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose Derived Stem Cells in people with Chronic Obstructive Pulmonary Disease, run by Bioheart, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.