Heart FailurePhase 1/2NCT03180450
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)
A Phase 1/2 study testing Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) and conventional treatment in people with Heart Failure, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) and conventional treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 31 Dec 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- volunteer to participate in clinical trial, and sign informed consent form
- with cardiac failure symptoms, including oppression in chest, breathe hard, lower limb edema. And new york heart association class as two to four
- heart color ultrasound indicate left ventricular ejection fraction (LVEF) < 40%
- content of serum NT-proBNP > 450pg/ml
Who cannot join
- with severe drug allergy history or allergic constitution
- patients were severe infected
- with malignant tumor or with high tumor marker
- with severe cardiorespiratory dysfunction, hematological system disease
- with severe mental disorder, cognitive impairment
- with persistent atrial fibrillation, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy or restrictive cardiomyopathy patients
Show all 12Show fewer
- end-stage renal insufficiency, pregnancy, or breast feeding women
- bleeding tendency, active gastrointestinal ulcer
- recent have major surgery, stroke, cancer, hepatic function insufficiency or other life-threatening condition.
- under other therapy that possibly influence MSC security or efficacy
- donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
- participant/donor: alcoholism, drug addicted, mental disease
Trial locations and contacts
1 site in 1 country.
China1 site
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, 010065
About this study
Official title: The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients
Read the detailed description
This is a randomized, paralleled study. Patients will be divided into two groups of treatment and control. all of them will receive conventional treatment based on specific condition, including digitalis, milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), and antiplatelet aggregation etc. Treatment group patients will receive hUC-MSC. Follow-up visit will occur on 3 months, 6 months, and 12 months after the cell transfusion. Vital signs, blood routine test, urine routine test, liver function examination, etc, will be placed to evaluate the safety of hUC-MSC treatment. And the change of symptoms to evaluate the efficacy.
- Conditions
- Heart Failure
- Being tested
- Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#), conventional treatment
- Keywords
- Heart Failure, Human Umbilical Cord Mesenchymal Stem Cells
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)Biological
Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.
conventional treatmentDrug
The drug and usage will be determined based on patient's condition, including milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), or antiplatelet aggregation etc.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v. Receives: Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#); Drug: conventional treatment |
| Control group | Placebo comparator | Conventional treatment Receives: Drug: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart color ultrasound evaluation
Criteria:
- Excellent: ejection fraction improve to > 50%;
- Efficient: ejection fraction improved;
- Inefficient: ejection fraction same as before treatment;
- Exacerbation: ejection fraction declined.
Measured: 12 months
Secondary outcomes (1)
Single therapy effectiveness evaluation
Evaluate criteria:
- Recovery: symptoms disappear
- Excellent: symptoms improved obviously
- Efficient: symptoms improved
- Inefficient: symptoms no change or worse
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start31 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Others
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nashundalai, Study director, Inner Mongolia International Mongolian HospitalLei Guo, Dr., Study chair, China-Japan Union Hospital, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180450
- Sponsor's protocol ID
- SCLnow-IMIMH-04
- Status last verified
- May 2025
- First submitted
- 6 Jun 2017
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
- ClinicalTrials.gov ID
- NCT03180450
- Acronym / sponsor ID
- SCLnow-IMIMH-04
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Human Umbilical Cord Mesenchymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Others
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 2017 (actual)
- 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 purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients
Detailed description
This is a randomized, paralleled study. Patients will be divided into two groups of treatment and control. all of them will receive conventional treatment based on specific condition, including digitalis, milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), and antiplatelet aggregation etc. Treatment group patients will receive hUC-MSC. Follow-up visit will occur on 3 months, 6 months, and 12 months after the cell transfusion. Vital signs, blood routine test, urine routine test, liver function examination, etc, will be placed to evaluate the safety of hUC-MSC treatment. And the change of symptoms to evaluate the efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#), Drug: conventional treatmentconventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v. |
| Control group | Placebo comparator | Drug: conventional treatmentConventional treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- volunteer to participate in clinical trial, and sign informed consent form
- with cardiac failure symptoms, including oppression in chest, breathe hard, lower limb edema. And new york heart association class as two to four
- heart color ultrasound indicate left ventricular ejection fraction (LVEF) < 40%
- content of serum NT-proBNP > 450pg/ml
Key exclusion criteria (12 listed)
- with severe drug allergy history or allergic constitution
- patients were severe infected
- with malignant tumor or with high tumor marker
- with severe cardiorespiratory dysfunction, hematological system disease
- with severe mental disorder, cognitive impairment
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 |
|---|---|---|
| Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation. | Biological | Treatment group |
| conventional treatmentThe drug and usage will be determined based on patient's condition, including milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), or antiplatelet aggregation etc. | Drug | Control group, Treatment group |
Primary outcome
Heart color ultrasound evaluation
Time frame: 12 months
Criteria: * Excellent: ejection fraction improve to > 50%; * Efficient: ejection fraction improved; * Inefficient: ejection fraction same as before treatment; * Exacerbation: ejection fraction declined.
1 secondary outcome
Single therapy effectiveness evaluation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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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.
Nashundalai study director
Inner Mongolia International Mongolian Hospital
Lei Guo, Dr. study chair
China-Japan Union Hospital, Jilin 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 Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) and conventional treatment in people with Heart Failure, run by Sclnow Biotechnology Co., Ltd. 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 4 inclusion and 12 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: paused, as of the sponsor's last update on 14 May 2025. 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. 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?
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 color ultrasound evaluation (time frame: 12 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 14 May 2025.