Myocardial InfarctionPhase 1/2TPAABPIHDNCT02504437
Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease
A Phase 1/2 study testing BMMSCs in people with Myocardial Infarction and Acute Myocardial Infarction, run by Academy Military Medical Science, China.
Trial summary
The purpose of the present study is to evaluate the efficacy of the preconditioned autologous bone marrow mesenchymal stem cells for patients with ischemic heart diseases. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Myocardial Infarction, Acute Myocardial Infarction, Ischemic Cardiomyopathy
- What is being tested?
- BMMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2017
- Phase
- Phase 1/2
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age under 75;
- Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy
- NYHA (New York Heart Association) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%;
- No infection diseases including HBV (hepatitis B virus), HCV (hepatitis C virus ), syphilis and AIDS;
- No psychiatric illnesses and speaking dysfunction;
- Informed consent.
Who cannot join
- More than 75 years old;
- LVEF<24%;
- Unstable hemodynamics, shock;
- Severe infection;
- Patients have tumor or other lethal diseases (expectation of life<6 months);
- Radiation patients;
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- hematopoietic malignancy including Haemophiliacs;
- Anemia (Hb<100g/L);
- The other clinical trial participants within one month;
- Abnormal increasing of the blood biochemical indicators that is not explained by the conditions;
- Informed refusal.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the present study is to evaluate the efficacy of the preconditioned autologous bone marrow mesenchymal stem cells for patients with ischemic heart diseases.
- Being tested
- BMMSCs
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMMSCsBiological
| Study group | Role | What they receive |
|---|---|---|
| pre-conditioned BMMSCs | Experimental | autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction. Receives: Biological: BMMSCs |
| BMMSCs | Active comparator | autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition. Receives: Biological: BMMSCs |
| Controls | Sham comparator | standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion. Receives: Biological: BMMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVEF (left ventricular ejection fraction)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academy Military Medical Science, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Responsible party
- Principal investigator, Xuetao Pei, Academy Military Medical Science, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504437
- Sponsor's protocol ID
- BMMSC-1
- Acronym
- TPAABPIHD
- Status last verified
- Jul 2015
- First submitted
- 14 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gao LR, Pei XT, Ding QA, Chen Y, Zhang NK, Chen HY, Wang ZG, Wang YF, Zhu ZM, Li TC, Liu HL, Tong ZC, Yang Y, Nan X, Guo F, Shen JL, Shen YH, Zhang JJ, Fei YX, Xu HT, Wang LH, Tian HT, Liu DQ, Yang Y. A critical challenge: dosage-related efficacy and acute complication intracoronary injection of autologous bone marrow mesenchymal stem cells in acute myocardial infarction. Int J Cardiol. 2013 Oct 9;168(4):3191-9. doi: 10.1016/j.ijcard.2013.04.112. Epub 2013 May 4.
PubMed 23651816
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT02504437
- Acronym / sponsor ID
- TPAABPIHD / BMMSC-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Academy Military Medical Science, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Study start
- Nov 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Jul 2015 (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 purpose of the present study is to evaluate the efficacy of the preconditioned autologous bone marrow mesenchymal stem cells for patients with ischemic heart diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pre-conditioned BMMSCs | Experimental | Biological: BMMSCsautologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction. |
| BMMSCs | Active comparator | Biological: BMMSCsautologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition. |
| Controls | Sham comparator | Biological: BMMSCsstandard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age under 75;
- Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy
- NYHA (New York Heart Association) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%;
- No infection diseases including HBV (hepatitis B virus), HCV (hepatitis C virus ), syphilis and AIDS;
- No psychiatric illnesses and speaking dysfunction;
Key exclusion criteria (11 listed)
- More than 75 years old;
- LVEF<24%;
- Unstable hemodynamics, shock;
- Severe infection;
- Patients have tumor or other lethal diseases (expectation of life<6 months);
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 |
|---|---|---|
| BMMSCs | Biological | BMMSCs, Controls, pre-conditioned BMMSCs |
Primary outcome
LVEF (left ventricular ejection fraction)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Background: PubMed 23651816Gao LR, Pei XT, Ding QA, Chen Y, Zhang NK, Chen HY, Wang ZG, Wang YF, Zhu ZM, Li TC, Liu HL, Tong ZC, Yang Y, Nan X, Guo F, Shen JL, Shen YH, Zhang JJ, Fei YX, Xu HT, Wang LH, Tian HT, Liu DQ, Yang Y. A critical challenge: dosage-related efficacy and acute complication intracoronary injection of autologous bone marrow mesenchymal stem cells in acute myocardial infarction. Int J Cardiol. 2013 Oct 9;168(4):3191-9. doi: 10.1016/j.ijcard.2013.04.112. Epub 2013 May 4.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMMSCs in people with Myocardial Infarction and Acute Myocardial Infarction, run by Academy Military Medical Science, China.
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 6 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: status not confirmed, as of the sponsor's last update on 22 Jul 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuetao Pei, M.D., Ph.D (8610-68164807, AMMS0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVEF (left ventricular ejection fraction) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02504437, which also lists 1 linked publication.
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 22 Jul 2015.