Cerebral InfarctionPhase 1NCT03186456
The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cerebral Infarction
A Phase 1 study testing Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) and Aspirin Tablet in people with Cerebral Infarction, 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 treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) and Aspirin Tablet
- Type of treatment
- Pill or oral medicine, 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
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient within 2 weeks onset of symptoms.
- Symptoms and signs of clinically definite acute cerebral infarction patients.
- CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient.
- Signed informed consent after understanding all possible benefits and harm.
Who cannot join
- allergic to basic drug
- with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis.
- tumor, injury, and parasites caused cerebral embolism
- rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism
- subject is processing thrombolytic therapy
- subject is pregnancy and of childbearing potential or breast feeding
Show all 14Show fewer
- participate in any other clinical trial in last 3 months
- bleeding tendency patient; severe bleeding tendency in last 3 month
- with gastric duodenal ulcer
- participants with severe liver and kidney, hematopoietic, and metabolic diseases; Or with liver and kidney function examination abnormal
- participants are intolerance with Aspirin Enteric-coated Tablets, or need other antiplatelet drugs
- participants: alcoholism, drug addicted, or other situations may complicated the results
- under other therapy that possibly influence MSC security or efficacy
- investigator supposes not suitable to participate this clinical trail
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: Study the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction
The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).
Read the detailed description
This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, evaluate the security and efficacy of hUC-MSC.
- Conditions
- Cerebral Infarction
- Being tested
- Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#), Aspirin Tablet
- Keywords
- acute cerebral infarction, umbilical cord mesenchymal stem cells
- Medical subject headings
- Cerebral Infarction
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 into by forearm intravenous transplantation, 0.5 - 1 *10^6/kg. once a month, total 3 times.
Aspirin TabletDrug
Drug: Aspirin Tablet, 100 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg Receives: Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#); Drug: Aspirin Tablet |
| Group 2 | Placebo comparator | Aspirin Tablet, 100mg/d; Placebo Receives: Drug: Aspirin Tablet |
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: 26 weeks
Secondary outcomes (3)
Modified Rankin Scale
After the first time transplantation, follow-up visit for 26 weeks. Based on Modified Rankin Scale, counting the percentage of different symptom changes to evaluate MSC efficacy:
- the percentage of participants run from 0-1, no symptom or no significant disability.
- the percentage of participants run from 0-2, no symptom or slight disability.
- the percentage of participants decline 2 scales compare to baseline.
- the percentage of participants decline 1 scale compares to baseline.
Measured: 26 weeks
Barthel activities of daily living (ADL) Index
Based on Activity of Daily Living Scale (ADL) to counting the percentage of patients in following condition:
- the percentage of patients with score > 75
- the decline of Barthel ADL Index range compares to baseline. Evaluate the efficacy of MSCs treatment
Measured: 26 weeks
NIH stroke scale (NIHSS)
According to NIHSS changes after the treatment, evaluate MSCs efficacy by counting the percentage of patients in following condition:
- the percentage of patients with score 0-1;
- the percentage of patients with score declined 7 compare to baseline;
- the percentage of patients with score declined 50% compare to baseline;
- the declined ranges compare to baseline
Measured: 26 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 Cerebral 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
- 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
- Temuqile, Study director, Inner Mongolia International Mongolian HospitalLei Guo, Dr., Study chair, China-Japan Union Hospital, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186456
- Sponsor's protocol ID
- SCLnow-IMIMH-02
- 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
- Study the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction
- ClinicalTrials.gov ID
- NCT03186456
- Acronym / sponsor ID
- SCLnow-IMIMH-02
- Conditions
- Cerebral Infarction
- Keywords
- acute cerebral infarction, umbilical cord mesenchymal stem cells
- Phase
- Phase 1
- 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 treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).
Detailed description
This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, 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 |
|---|---|---|
| Group 1 | Experimental | Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#), Drug: Aspirin TabletAspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg |
| Group 2 | Placebo comparator | Drug: Aspirin TabletAspirin Tablet, 100mg/d; Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient within 2 weeks onset of symptoms.
- Symptoms and signs of clinically definite acute cerebral infarction patients.
- CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient.
- Signed informed consent after understanding all possible benefits and harm.
Key exclusion criteria (14 listed)
- allergic to basic drug
- with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis.
- tumor, injury, and parasites caused cerebral embolism
- rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism
- subject is processing thrombolytic therapy
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 into by forearm intravenous transplantation, 0.5 - 1 *10^6/kg. once a month, total 3 times. | Biological | Group 1 |
| Aspirin TabletDrug: Aspirin Tablet, 100 mg/d | Drug | Group 1, Group 2 |
Primary outcome
Treatment related-adverse events counting
Time frame: 26 weeks
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
3 secondary outcomes
Modified Rankin Scale
Time frame: 26 weeks
Barthel activities of daily living (ADL) Index
Time frame: 26 weeks
NIH stroke scale (NIHSS)
Time frame: 26 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.
Temuqile 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 study testing Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) and Aspirin Tablet in people with Cerebral Infarction, 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 14 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 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.
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: 26 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.