Ischemic StrokePhase 2NCT07197606
Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in Subacute Ischemic Stroke
A Phase 2 study testing IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells) in people with Ischemic Stroke, run by Shanghai IxCell Biotechnology Co., LTD at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the anterior circulation during the recovery phase. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤70 years, regardless of gender.
- 14 to 90 days after ischemic stroke.
- Clinical diagnosis of anterior circulation ischemic stroke.
- National Institutes of Health Stroke Scale (NIHSS) score is 6-20 points (inclusive), with NIHSS motor arm (item 5) or motor leg (item 6) score of 2-4 points, and NIHSS level of consciousness item (1a) score <2 points.
- It was anticipated that participants would either be able to give informed consent or have a legal representative who could do so.
Who cannot join
- People who had a history of epilepsy, dementia, Parkinson's disease, severe depression, or other neurological or psychiatric disorders.
- Intracranial hemorrhagic conditions.
- Pre-stroke mRS score >1.
- Severe cardiovascular disease.
- Severe pulmonary diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
Gaoting Ma, MD, +86 18301579891, demo_doctor@163.com
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-S in Patients With Ischemic Stroke in the Recovery Phase
The goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the anterior circulation during the recovery phase. Researchers will compare hUC-MSCs to a placebo to determine whether hUC-MSCs treatment is effective in treating recovery-phase anterior circulation ischemic stroke.
Read the detailed description
This study aims to further evaluate the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in the treatment of stroke. Eligible participants will be randomized to receive either intravenous infusions of hUC-MSCs or a matching placebo. Over the 12-month study period, participants will be required to attend regular clinic visits for comprehensive neurological assessments, including the Fugl-Meyer Assessment (FMA), Modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Mini-Mental State Examination (MMSE), as well as vascular imaging studies and biomarker analyses. Additionally, participants (or their caregivers, where applicable) will be instructed to consistently document neurological symptoms, functional activities, and the use of any rehabilitation medications or assistive devices.
- Conditions
- Ischemic Stroke
- Being tested
- Placebo, IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Intravenous injection of placebo
IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)Drug
Intravenous injection of IxCell hUC-MSC-S
| Study group | Role | What they receive |
|---|---|---|
| MSCs treatment | Experimental | Intravenous injection of mesenchymal stem cells Receives: Drug: IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells) |
| Placebo | Placebo comparator | Intravenous injection of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment motor score
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based scale used to evaluate motor impairment. Its motor score, which ranges from 0 to 100, serves as a key parameter for quantifying motor recovery, where a higher score indicates better motor function.
Measured: 12 months
Secondary outcomes (4)
Modified Rankin Scale
The Modified Rankin Scale (mRS) is designed to evaluate the degree of dependence in daily activities rather than specific impairments. The mRS is a simple ordinal scale ranging from 0 to 6, where 0 indicates no symptoms and 6 indicates death. A lower score on the scale signifies a better level of independence and a lower degree of disability.
Measured: 12 months
National Institutes of Health Stroke Scale
The National Institutes of Health Stroke Scale (NIHSS) is designed to evaluate the effects of a stroke on key functional domains such as consciousness, vision, motor strength, sensation, and language.The NIHSS score ranges from 0 to 42, with a higher score indicating more severe neurological deficits.
Measured: 12 months
Barthel Index
The Barthel Index (BI) is commonly employed to evaluate functional disability and monitor rehabilitation progress in patients with chronic conditions or following events such as stroke. The total score ranges from 0 to 100, with a higher score indicating a greater degree of functional independence.
Measured: 12 months
Mini-Mental State Examination
The Mini-Mental State Examination (MMSE) is a standardized screening tool designed to provide a quick assessment of an individual's global cognitive function.The total score ranges from 0 to 30, with a higher score indicating better cognitive performance.
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 posted29 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai IxCell Biotechnology Co., LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197606
- Sponsor's protocol ID
- LC-MSC-IS25001
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The general demographic data of participants, as well as clinical trial results including scoring data and safety data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-S in Patients With Ischemic Stroke in the Recovery Phase
- ClinicalTrials.gov ID
- NCT07197606
- Acronym / sponsor ID
- LC-MSC-IS25001
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Shanghai IxCell Biotechnology Co., LTDUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Sep 2025 (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 goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the anterior circulation during the recovery phase. Researchers will compare hUC-MSCs to a placebo to determine whether hUC-MSCs treatment is effective in treating recovery-phase anterior circulation ischemic stroke.
Detailed description
This study aims to further evaluate the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in the treatment of stroke. Eligible participants will be randomized to receive either intravenous infusions of hUC-MSCs or a matching placebo. Over the 12-month study period, participants will be required to attend regular clinic visits for comprehensive neurological assessments, including the Fugl-Meyer Assessment (FMA), Modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Mini-Mental State Examination (MMSE), as well as vascular imaging studies and biomarker analyses. Additionally, participants (or their caregivers, where applicable) will be instructed to consistently document neurological symptoms, functional activities, and the use of any rehabilitation medications or assistive devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSCs treatment | Experimental | Drug: IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)Intravenous injection of mesenchymal stem cells |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous injection of placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years and ≤70 years, regardless of gender.
- 14 to 90 days after ischemic stroke.
- Clinical diagnosis of anterior circulation ischemic stroke.
- National Institutes of Health Stroke Scale (NIHSS) score is 6-20 points (inclusive), with NIHSS motor arm (item 5) or motor leg (item 6) score of 2-4 points, and NIHSS level of consciousness item (1a) score <2 points.
- It was anticipated that participants would either be able to give informed consent or have a legal representative who could do so.
Key exclusion criteria (5 listed)
- People who had a history of epilepsy, dementia, Parkinson's disease, severe depression, or other neurological or psychiatric disorders.
- Intracranial hemorrhagic conditions.
- Pre-stroke mRS score >1.
- Severe cardiovascular disease.
- Severe pulmonary diseases.
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 |
|---|---|---|
| PlaceboIntravenous injection of placebo | Drug | Placebo |
| IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)Intravenous injection of IxCell hUC-MSC-S | Drug | MSCs treatment |
Primary outcome
Fugl-Meyer Assessment motor score
Time frame: 12 months
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based scale used to evaluate motor impairment. Its motor score, which ranges from 0 to 100, serves as a key parameter for quantifying motor recovery, where a higher score indicates better motor function.
4 secondary outcomes
Modified Rankin Scale
Time frame: 12 months
National Institutes of Health Stroke Scale
Time frame: 12 months
Barthel Index
Time frame: 12 months
Mini-Mental State Examination
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Yes. The general demographic data of participants, as well as clinical trial results including scoring data and safety data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells) in people with Ischemic Stroke, run by Shanghai IxCell 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Sep 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Xiao, PHD (+86 21 68911597, xiaoming@ixcell.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment motor score (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 29 Sep 2025.