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Cerebral InfarctionPhase 1/2NCT03176498

Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.

A Phase 1/2 study testing Allogeneic umbilical cord mesenchymal stem cell and Aspirin Enteric-coated Tablets & Atorvastatin Calcium in people with Cerebral Infarction, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Cerebral Infarction
What is being tested?
Allogeneic umbilical cord mesenchymal stem cell and Aspirin Enteric-coated Tablets & Atorvastatin Calcium
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • proved cerebral infarction by CT or MRI.
  • no cerebrovascular disease before
  • signed informed consent form

Who cannot join

  • serious body and intracranial lesions (tumor, infection, etc.)
  • patients repeated cerebral infarction attacks
  • multi-foci of cerebral infarction
  • history of drug dependence and mental disease
  • disturbance of consciousness and non-compliance patients
  • subjects who are HIV positive
Show all 9Show fewer
  • pregnant or lactation
  • donor: HIV infected, Active hepatitis B/C infected, Syphilis antibody positive
  • subjects/ donor: alcoholism, drug addicts or mental disease

Trial locations and contacts

1 site in 1 country.

China1 site

  • Inner Mongolia International Mongolian Hospital

    Hohhot, Inner Mongolia, 010065

Other trials in China

About this study

Official title: The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.

This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

Read the detailed description

40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.

Being tested
Allogeneic umbilical cord mesenchymal stem cell, Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Keywords
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 cellBiological

    Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)

  • Aspirin Enteric-coated Tablets & Atorvastatin CalciumDrug

    Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.

Study groups in NCT03176498
Study groupRoleWhat they receive
Experimental groupExperimentalBasic medication：Aspirin Enteric-coated Tablets \& Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells
Receives: Biological: Allogeneic umbilical cord mesenchymal stem cell; Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Control groupPlacebo comparatorBasic medication：Aspirin Enteric-coated Tablets \& Atorvastatin Calcium; Placebo：saline
Receives: Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motor function analysis

    Based on Activity of Daily Living Scale (ADL) to analysis efficacy of cell treatment.The score of patient with upper limb >60, and total score >90 is considered good recovery.

    Measured: 6 months

Secondary outcomes (3)

  1. Neurological deficits analysis

    According to Chinese scale of clinical neurologic deficit to analysis, the result as follow:

    • Excellent: after treatment, patient with consciousness, and clinical symptoms improved;
    • Effective: vital signs and main symptoms in remission;
    • Inefficient: no obvious improvement or condition worsened.

    Measured: 6 months

  2. Limb motor function analysis

    Using fugl-meyer assessment evaluate motor function. Mild movement disorder: 96 - 99; Moderate movement disorder: 85 - 95; Obvious movement disorder: 50 - 84; Serious movement disorder: < 50

    Measured: 6 months

  3. Barthel Index analysis

    Obvious effective: Barthel Index score between 96 - 99, patient with self care ability.

    Effective:Barthel Index score between 70 - 89, patient with condition improved. Invalid: The effect do not meet above standards.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Why it stopped: Others

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03176498
Sponsor's protocol ID
SCLnow-IMIMH-01
Status last verified
Dec 2025
First submitted
23 May 2017
Last updated
23 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogeneic umbilical cord mesenchymal stem cell and Aspirin Enteric-coated Tablets & Atorvastatin Calcium 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 3 inclusion and 9 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?

Motor function analysis (time frame: 6 months). 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 NCT03176498.

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.

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