Dilated CardiomyopathyPhase 1/2NCT01219452
Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy
A Phase 1/2 study testing umbilical cord mesenchymal stem cells in people with Dilated Cardiomyopathy, run by Qingdao University at 1 site in China.
Trial summary
The main aim of the study is to determine whether intramuscular injection of umbilical cord mesenchymal stem cells can improve the ventricular function of children with idiopathic dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible mechanism of the improvement of ventricular function… Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2012
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of both genders with established clinical and echocardiographic diagnosis of dilated cardiomyopathy whose parents accept to participate in the trail.
- They should have symptoms and /or signs of heart failure, despite optimized medical treatment.
- Ejection fraction of left ventricular should be less than 50%, but more than 20%.
Who cannot join
- associate coronary artery disease.
- any history or suspicion of a toxic , pharmacologic or deposit etiology.
- associated malignant or pre -malignant systemic disease.
- associated hematologic disorder.
- a history of sustained ventricular tachycardia or fibrillation.
- a history of syncope during the previous year, or with an active infectious disease or positive tests to viral disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, 266003
Jianxia Hu, MD, 86-0532-82911676, qdyxyhjx@126.com
Hong Gao, MS, 86-0532-82911676, honggaogloria@gmail.com
About this study
Official title: Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy
The main aim of the study is to determine whether intramuscular injection of umbilical cord mesenchymal stem cells can improve the ventricular function of children with idiopathic dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate the safety of intramuscular injection of umbilical cord mesenchymal stem cell.
Read the detailed description
Children with Idiopathic dilated cardiomyopathy class II to III NYHA with ejection fraction over 20% were selected for phase II clinical trial, umbilical cord mesenchymal stem cells were injected into limb muscle and followed for 6 months.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- umbilical cord mesenchymal stem cells
- Keywords
- Dilated Cardiomyopathy, Umbilical cord, Mesenchymal stem cells, Children
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellsBiological
Also called mesenchymal stem cells
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | intramuscular injection of umbilical cord mesenchymal stem cell Receives: Biological: umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
echocardiography
Measured: 3 months
Secondary outcomes (3)
24h HOLTER
Measured: 2 months
The level of serum BNP,TNI,HGF、LIF and G/M-CSF
Measured: 3 months
The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Investigators
- zipu li, MD Phd, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219452
- Sponsor's protocol ID
- MSCKX002
- Status last verified
- May 2010
- First submitted
- 12 Oct 2010
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01219452
- Acronym / sponsor ID
- MSCKX002
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Dilated Cardiomyopathy, Umbilical cord, Mesenchymal stem cells, Children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Oct 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 main aim of the study is to determine whether intramuscular injection of umbilical cord mesenchymal stem cells can improve the ventricular function of children with idiopathic dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate the safety of intramuscular injection of umbilical cord mesenchymal stem cell.
Detailed description
Children with Idiopathic dilated cardiomyopathy class II to III NYHA with ejection fraction over 20% were selected for phase II clinical trial, umbilical cord mesenchymal stem cells were injected into limb muscle and followed for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | Biological: umbilical cord mesenchymal stem cellsintramuscular injection of umbilical cord mesenchymal stem cell |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of both genders with established clinical and echocardiographic diagnosis of dilated cardiomyopathy whose parents accept to participate in the trail.
- They should have symptoms and /or signs of heart failure, despite optimized medical treatment.
- Ejection fraction of left ventricular should be less than 50%, but more than 20%.
Key exclusion criteria (6 listed)
- associate coronary artery disease.
- any history or suspicion of a toxic , pharmacologic or deposit etiology.
- associated malignant or pre -malignant systemic disease.
- associated hematologic disorder.
- a history of sustained ventricular tachycardia or fibrillation.
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 |
|---|---|---|
| umbilical cord mesenchymal stem cellsAlso: mesenchymal stem cellsMultiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord. | Biological | umbilical cord mesenchymal stem cells |
Primary outcome
echocardiography
Time frame: 3 months
3 secondary outcomes
24h HOLTER
Time frame: 2 months
The level of serum BNP,TNI,HGF、LIF and G/M-CSF
Time frame: 3 months
The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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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.
zipu li, MD Phd study director
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing umbilical cord mesenchymal stem cells in people with Dilated Cardiomyopathy, run by Qingdao University at 1 site in 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 3 inclusion and 6 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 28 Oct 2010. 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 China. 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.
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 Jianxia Hu, MD (86-0532-82911676, qdyxyhjx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
echocardiography (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 28 Oct 2010.