Myelodysplastic SyndromesPhase 1/2NCT03184935
Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)
A Phase 1/2 study testing Allogeneic umbilical cord mesenchymal stem cells and Decitabine in people with Myelodysplastic Syndromes, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The purposes of the study is to determine the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Allogeneic umbilical cord mesenchymal stem cells and Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2026to 31 Dec 2027
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MDS patients with international prostate symptom score is moderate or severe symptoms
Who cannot join
- with serious renal function impaired
- with other organ function abnormal: acute hepatitis B, ejection fraction < 40%, serum bilirubin > 3mg/dl, liver function tests abnormal, central nervous system disease, mental disease
- bad physical condition (Karmofsky < 60%)
- without signing informed consent form
- under other therapy that possibly influence MSC security or efficacy
- HIV or other serious disease infection
- Donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
- Donor/ participants: 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: Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
The purposes of the study is to determine the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients.
Read the detailed description
This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Decitabine). Patients in experimental group will receive hUC-MSC, while control group receive placebo (normal saline), four weeks as a course of treatment. All of the patients accept examination before treatment, including
- diagnostic projects: bone marrow test, peripheral blood classification, chromosome, and MDS fusion gene test, etc.;
- routine examination: blood, urine, and stool routine test, X-ray film in chest, electrocardiogram, etc.;
- stem cell-based medicinal products usage, dosage, time, and course of treatment.
Then, patients will accept routine examination everyday, and after treatment, investigator will follow-up for 6 months, to evaluate the security and efficacy of hUC-MSC.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Allogeneic umbilical cord mesenchymal stem cells, Decitabine
- Keywords
- Myelodysplastic Syndromes, mesenchymal stem cells
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic umbilical cord mesenchymal stem cellsBiological
Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)
DecitabineDrug
Decitabine，20mg/m^2/d
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells. Receives: Biological: Allogeneic umbilical cord mesenchymal stem cells; Drug: Decitabine |
| Control group | Placebo comparator | Basic medication: Decitabine; placebo: saline. Receives: Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related-adverse events counting
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
Measured: 16 weeks
Secondary outcomes (1)
Improvement in clinical function
According to 'Diagnostic and Curative Criteria of Hematological Diseases' 3rd edition edited by Zhang Zhinan and Shen Di, evaluate the hUC-MSCs efficacy. The result as follow:
- complete remission (CR);
- partial remission (PR);
- stable disease (SD);
- progressive disease (PD)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start31 Dec 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (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 Myelodysplastic SyndromesStudies 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, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shana Chen, Study director, Inner Mongolia International Mongolian HospitalLei Guo, Study chair, China-Japan Union Hospital, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184935
- Sponsor's protocol ID
- SCLnow-IMIMH-03
- Status last verified
- Dec 2025
- First submitted
- 6 Jun 2017
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT03184935
- Acronym / sponsor ID
- SCLnow-IMIMH-03
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Myelodysplastic Syndromes, mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Others
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 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 determine the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients.
Detailed description
This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Decitabine). Patients in experimental group will receive hUC-MSC, while control group receive placebo (normal saline), four weeks as a course of treatment. All of the patients accept examination before treatment, including
- diagnostic projects: bone marrow test, peripheral blood classification, chromosome, and MDS fusion gene test, etc.;
- routine examination: blood, urine, and stool routine test, X-ray film in chest, electrocardiogram, etc.;
- stem cell-based medicinal products usage, dosage, time, and course of treatment.
Then, patients will accept routine examination everyday, and after treatment, investigator will follow-up for 6 months, to evaluate the security and efficacy of hUC-MSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Allogeneic umbilical cord mesenchymal stem cells, Drug: DecitabineBasic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells. |
| Control group | Placebo comparator | Drug: DecitabineBasic medication: Decitabine; placebo: saline. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- MDS patients with international prostate symptom score is moderate or severe symptoms
Key exclusion criteria (8 listed)
- with serious renal function impaired
- with other organ function abnormal: acute hepatitis B, ejection fraction < 40%, serum bilirubin > 3mg/dl, liver function tests abnormal, central nervous system disease, mental disease
- bad physical condition (Karmofsky < 60%)
- without signing informed consent form
- under other therapy that possibly influence MSC security or efficacy
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 cellsExperimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#) | Biological | Experimental group |
| DecitabineDecitabine，20mg/m^2/d | Drug | Control group, Experimental group |
Primary outcome
Treatment related-adverse events counting
Time frame: 16 weeks
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
1 secondary outcome
Improvement in clinical function
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- 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.
Shana Chen study director
Inner Mongolia International Mongolian Hospital
Lei Guo 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 and Decitabine in people with Myelodysplastic Syndromes, 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 1 inclusion and 8 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 23 Apr 2026. 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?
Treatment related-adverse events counting (time frame: 16 weeks). 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 23 Apr 2026.