Heart Failure, CongestivePhase 1NCT00128258
Autologous/Allogeneic Progenitor Stem Cell Therapy for Congestive Heart Failure
A Phase 1 study testing Injection of bone marrow cells in the heart and Biological bone marrow cell therapy in people with Heart Failure, Congestive, run by Amit, Patel N, M.D..
Trial summary
This research study is being performed to find out more information about the safety and effectiveness of injecting bone marrow progenitor cells (BMPCs) from one's own hip bone into one's heart muscle. The BMPCs are the cells from which the different types of blood and other cells grow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Injection of bone marrow cells in the heart and Biological bone marrow cell therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2005to 1 Dec 2016
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years.
- Congestive heart failure with ejection fraction <= 35.
- Candidates for ventricular device placement as a bridge to transplant.
- Serum bilirubin, SGOT and SGPT <= 2.5 times the upper level of normal.
- Serum creatinine < 2.0 times normal or no dialysis.
- New York Heart Association (NYHA) performance status > 3.
- Negative pregnancy test (in women with childbearing potential).
Who cannot join
- Pregnant or breastfeeding women.
- History of prior radiation exposure.
- History of bone marrow disorder.
- History of abnormal bleeding or clotting.
- History of liver cirrhosis.
- Inability to obtain 1 x 10^6 CD 34+ cells after bone marrow processing.
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- Acute myocardial infarction < 6 days from acute event.
- Prior malignancy in the 5 years before treatment in this study (other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer).
- Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
- Eligible for destination ventricular assist device placement.
- Unable to have 250cc bone marrow harvested.
About this study
Official title: Phase 1 Study: Autologous/Allogeneic Bone Marrow Progenitor Cell Treatment for Heart Failure
This research study is being performed to find out more information about the safety and effectiveness of injecting bone marrow progenitor cells (BMPCs) from one's own hip bone into one's heart muscle. The BMPCs are the cells from which the different types of blood and other cells grow.
In patients with heart failure, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. The investigators are trying to find out if the injection of these BMPCs can make a change in the functioning of these areas of the heart muscle. Data from studies around the world have suggested that when patients with heart failure receive these cells by direct injection into their hearts they show signs of recovered heart function, however, there has been no evidence from actual studies of the cells of the patient's hearts to show how this process works. It is the investigator's plan to inject an eligible participant's heart with cells that are from one's own bone marrow during an operation to receive a ventricular assist device (VAD) or partial artificial heart and then to study the function of the heart while awaiting a heart transplant. The investigators will then examine the heart after it has been removed as part of the regular heart transplant operation for any microscopic changes (changes too small to be seen by the unaided eye but large enough to be studied under a microscope) at the site where the cells are injected. Participants will have no change in the chances of receiving a heart transplant by agreeing to participate in this study. There will also be no delay in receiving a VAD operation while waiting to participate in this study. This Phase I study has been cleared by the Food and Drug Administration (FDA) to enroll and treat patients. The Center for Biologics Evaluation and Research Investigational New Drug number (IND BB #) is 12304. (A Phase I trial is a research study using techniques or products in the first-stage or for the first time in human subjects).
- Conditions
- Heart Failure, Congestive
- Being tested
- Injection of bone marrow cells in the heart, Biological bone marrow cell therapy
- Keywords
- Stem Cell, Heart Failure, Bone Marrow
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of bone marrow cells in the heartProcedure or surgery
Biological implant into the heart
Biological bone marrow cell therapyBiological
Biological implant into the heart
| Study group | Role | What they receive |
|---|---|---|
| open | Experimental | open treatment Receives: Procedure: Injection of bone marrow cells in the heart; Biological: Biological bone marrow cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart function at 3 months after implant
Measured: 3 months
Secondary outcomes (1)
Toxicity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study start1 May 2005
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Why it stopped: study no longer at pittsburgh
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amit, Patel N, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit N. Patel MD MS, Amit, Patel N, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128258
- Sponsor's protocol ID
- #:0504126
- Status last verified
- Jan 2018
- First submitted
- 8 Aug 2005
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study: Autologous/Allogeneic Bone Marrow Progenitor Cell Treatment for Heart Failure
- ClinicalTrials.gov ID
- NCT00128258
- Acronym / sponsor ID
- #:0504126
- Conditions
- Heart Failure, Congestive
- Keywords
- Stem Cell, Heart Failure, Bone Marrow
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study no longer at pittsburgh
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Amit, Patel N, M.D.University, hospital or other
- Study start
- 1 May 2005 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 9 Aug 2005 (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.
This research study is being performed to find out more information about the safety and effectiveness of injecting bone marrow progenitor cells (BMPCs) from one's own hip bone into one's heart muscle. The BMPCs are the cells from which the different types of blood and other cells grow.
In patients with heart failure, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. The investigators are trying to find out if the injection of these BMPCs can make a change in the functioning of these areas of the heart muscle. Data from studies around the world have suggested that when patients with heart failure receive these cells by direct injection into their hearts they show signs of recovered heart function, however, there has been no evidence from actual studies of the cells of the patient's hearts to show how this process works. It is the investigator's plan to inject an eligible participant's heart with cells that are from one's own bone marrow during an operation to receive a ventricular assist device (VAD) or partial artificial heart and then to study the function of the heart while awaiting a heart transplant. The investigators will then examine the heart after it has been removed as part of the regular heart transplant operation for any microscopic changes (changes too small to be seen by the unaided eye but large enough to be studied under a microscope) at the site where the cells are injected. Participants will have no change in the chances of receiving a heart transplant by agreeing to participate in this study. There will also be no delay in receiving a VAD operation while waiting to participate in this study. This Phase I study has been cleared by the Food and Drug Administration (FDA) to enroll and treat patients. The Center for Biologics Evaluation and Research Investigational New Drug number (IND BB #) is 12304. (A Phase I trial is a research study using techniques or products in the first-stage or for the first time in human subjects).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open | Experimental | Procedure: Injection of bone marrow cells in the heart, Biological: Biological bone marrow cell therapyopen treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >=18 years.
- Congestive heart failure with ejection fraction <= 35.
- Candidates for ventricular device placement as a bridge to transplant.
- Serum bilirubin, SGOT and SGPT <= 2.5 times the upper level of normal.
- Serum creatinine < 2.0 times normal or no dialysis.
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women.
- History of prior radiation exposure.
- History of bone marrow disorder.
- History of abnormal bleeding or clotting.
- History of liver cirrhosis.
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 |
|---|---|---|
| Injection of bone marrow cells in the heartBiological implant into the heart | Procedure or surgery | open |
| Biological bone marrow cell therapyBiological implant into the heart | Biological | open |
Primary outcome
Heart function at 3 months after implant
Time frame: 3 months
1 secondary outcome
Toxicity
Time frame: 3 months
Results and safety
The study was stopped early (reason given: study no longer at pittsburgh). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Injection of bone marrow cells in the heart and Biological bone marrow cell therapy in people with Heart Failure, Congestive, run by Amit, Patel N, M.D..
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 7 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: stopped early, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: study no longer at pittsburgh). Results are not available in the source record.
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?
Heart function at 3 months after implant (time frame: 3 months). 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 19 Jan 2018.