Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)CSHSBMMCTTHDNCT01234181
Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases
A study testing Hypoxia-stressed BMSCs transplantation to cure MI in people with Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)
- What is being tested?
- Hypoxia-stressed BMSCs transplantation to cure MI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Dec 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute Myocardial Infarction(within one month);
- Age under 65;
- Infarction related wall motion abnormality on echocardiography;
- Infarction related TIMI flow grades 3 on coronary angiography during cell injection;
- Informed consent;
Who cannot join
- Active infection, or hematopoietic malignancy;
- Patients have tumor or other lethal diseases;
- Informed refusal
About this study
Official title: Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Intracoronary Transplantation in Myocardial Infarction and Other Heart Diseases.
The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.
- Being tested
- Hypoxia-stressed BMSCs transplantation to cure MI
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxia-stressed BMSCs transplantation to cure MIProcedure or surgery
Experimental group: intracoronary injection of 10^7 BMSCs Sham Comparator: inject the same volume saline
| Study group | Role | What they receive |
|---|---|---|
| BMSCs transplantation | Experimental | Not described Receives: Procedure: Hypoxia-stressed BMSCs transplantation to cure MI |
| No BMSCs transplantation | Sham comparator | Not described Receives: Procedure: Hypoxia-stressed BMSCs transplantation to cure MI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart function
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 posted4 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Jian'an Wang, M.D, Ph.D, Principal investigator, 2nd Affiliated Hospital, School of Medicine at Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234181
- Sponsor's protocol ID
- SAHZJU CT001
- Other IDs
- SFDA2010
- Acronym
- CSHSBMMCTTHD
- Status last verified
- Nov 2010
- First submitted
- 3 Nov 2010
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hu X, Yu SP, Fraser JL, Lu Z, Ogle ME, Wang JA, Wei L. Transplantation of hypoxia-preconditioned mesenchymal stem cells improves infarcted heart function via enhanced survival of implanted cells and angiogenesis. J Thorac Cardiovasc Surg. 2008 Apr;135(4):799-808. doi: 10.1016/j.jtcvs.2007.07.071.
PubMed 18374759Hu X, Huang X, Yang Q, Wang L, Sun J, Zhan H, Lin J, Pu Z, Jiang J, Sun Y, Xiang M, Liu X, Xie X, Yu X, Chen Z, Tse HF, Zhang J, Wang J. Safety and efficacy of intracoronary hypoxia-preconditioned bone marrow mononuclear cell administration for acute myocardial infarction patients: The CHINA-AMI randomized controlled trial. Int J Cardiol. 2015 Apr 1;184:446-451. doi: 10.1016/j.ijcard.2015.02.084. Epub 2015 Feb 25.
PubMed 25755063
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Intracoronary Transplantation in Myocardial Infarction and Other Heart Diseases.
- ClinicalTrials.gov ID
- NCT01234181
- Acronym / sponsor ID
- CSHSBMMCTTHD / SAHZJU CT001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Nov 2010 (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 this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMSCs transplantation | Experimental | Procedure: Hypoxia-stressed BMSCs transplantation to cure MI |
| No BMSCs transplantation | Sham comparator | Procedure: Hypoxia-stressed BMSCs transplantation to cure MI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of acute Myocardial Infarction(within one month);
- Age under 65;
- Infarction related wall motion abnormality on echocardiography;
- Infarction related TIMI flow grades 3 on coronary angiography during cell injection;
- Informed consent;
Key exclusion criteria (3 listed)
- Active infection, or hematopoietic malignancy;
- Patients have tumor or other lethal diseases;
- Informed refusal
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 |
|---|---|---|
| Hypoxia-stressed BMSCs transplantation to cure MIExperimental group: intracoronary injection of 10^7 BMSCs Sham Comparator: inject the same volume saline | Procedure or surgery | BMSCs transplantation, No BMSCs transplantation |
Primary outcome
Heart function
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 4 Nov 2010.
- Background: PubMed 18374759Hu X, Yu SP, Fraser JL, Lu Z, Ogle ME, Wang JA, Wei L. Transplantation of hypoxia-preconditioned mesenchymal stem cells improves infarcted heart function via enhanced survival of implanted cells and angiogenesis. J Thorac Cardiovasc Surg. 2008 Apr;135(4):799-808. doi: 10.1016/j.jtcvs.2007.07.071.
- Derived from this study: PubMed 25755063Hu X, Huang X, Yang Q, Wang L, Sun J, Zhan H, Lin J, Pu Z, Jiang J, Sun Y, Xiang M, Liu X, Xie X, Yu X, Chen Z, Tse HF, Zhang J, Wang J. Safety and efficacy of intracoronary hypoxia-preconditioned bone marrow mononuclear cell administration for acute myocardial infarction patients: The CHINA-AMI randomized controlled trial. Int J Cardiol. 2015 Apr 1;184:446-451. doi: 10.1016/j.ijcard.2015.02.084. Epub 2015 Feb 25.
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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.
Jian'an Wang, M.D, Ph.D principal investigator
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia-stressed BMSCs transplantation to cure MI in people with Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 5 inclusion and 3 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 4 Nov 2010. 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.
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?
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 (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 NCT01234181, which also lists 2 linked publications.
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 4 Nov 2010.