Ischemic StrokePhase 1/2NCT04590118
Allogeneic Mesenchymal Stem Cells for the Survivors of Ischemic Stroke Trial (ASSIST)
A Phase 1/2 study testing it-hMSC in people with Ischemic Stroke, run by Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of single injection of it-hMSC in patients with ischemic stroke in a multicenter, blind, randomized, placebo controlled trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- it-hMSC
- 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
- 26 Apr 2021to 1 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older.
- Clinical diagnosis of ischemic stroke for more than 6 months.
- Imaging findings suggestive of ischemic stroke with functional deficits at initial diagnosis and enrollment.
- Severe neurological impairment associated with the diagnosis of ischemic stroke that resulted in the subject needing assistance to walk or not being able to perform general daily activities independently.
- No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment.
- NIHSS score between 6-20.
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- Life expectancy longer than 12 months.
- Prior to treatment, the patient received standard medical care for secondary prevention of ischemic stroke, including but not limited to appropriate blood pressure and cholesterol control measures, use of antiplatelet agents or anticoagulants (except when prohibited).
- Understand and provide signed informed consent, or have a designated legal guardian or spouse make such decision voluntarily on behalf of the subject.
- Expected that the patient will receive standard medical care for secondary prevention of ischemic stroke and participate in all planned safe follow-up visits reasonably.
- Organ function as defined by the following criteria:
- AST ≤ 2.5×ULN ALT ≤ 2.5×ULN TSB ≤1.5×ULN PT ≤1.25×ULN and PTT ≤1.25×ULN in subjects who did not receive antithrombotic therapy Serum albumin ≥ 3.0g/dL ANC ≥ 1,500/μL Platelets ≥ 150,000/μL Hemoglobin ≥ 9.0g/dL Serum creatinine ≤ 1.5×ULN Serum amylase or lipase ≤ 1.0×ULN
Who cannot join
- History of epilepsy.
- History of cancer.
- History of brain trauma and brain tumor.
- Positive for hepatitis B surface antigen, E antigen, E antibody, core antibody, hepatitis C, HIV or RPR.
- Myocardial infarction occurred within six months of study entry.
- Any other medical problems of clinical significance, abnormal mental or test results that the investigator or sponsor determined participating in the study pose a safety risk to the subject.
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- Imaging findings suggestive of subarachnoid hemorrhage or intracerebral hemorrhage in the past 12 months.
- Participation in any study of experimental drug or device within 3 months.
- Participation in other study related to stem cell-therapy.
- History of drug or alcohol abuse within 1 year.
- Pregnant, lactating or planning to become pregnant during the trial.
- Allergic to cattle or pork products.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Yongjun Wang, MD, 010-59978538, yongjunwang1962@gmail.com
About this study
Official title: A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Multicenter, Blind, Randomized, Placebo Controlled Single Injection of It-hMSC in Patients With Ischemic Stroke
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of single injection of it-hMSC in patients with ischemic stroke in a multicenter, blind, randomized, placebo controlled trial
Read the detailed description
Stroke is a leading cause of disability. According to the comprehensive standardized prevalence estimation in 2016, 12.42 million people older than 40 years in China are currently suffering from stroke or have ever suffered from stroke. The overall prevalence rate of stroke in China was 1,596 per 100,000 people in 2016, 4.6 times higher than the rate of 345.1 per 100,000 people in 2013 and 70% of the survivors have disabilities in varying degrees. In addition to rehabilitation therapy, there is no therapeutic drugs of remarkable curative effect for the treatment of ischemic stroke patients. The latest data show that the annual recurrence rate of ischemic stroke in China is as high as 17.7%.
Allogeneic mesenchymal stem cells have been used in many clinical studies for different diseases. In addition to differentiating into multiple cell types and promoting the recovery and repair of the brain by replacing damaged cells, mesenchymal stem cells also secrete cytokines and neurotrophic factors to support and stimulate the growth of other endogenous cells. Meanwhile, mesenchymal stem cells also have anti-inflammatory and immunomodulatory functions. These characteristics of mesenchymal stem cells provide a new therapy for the treatment of stroke.
- Conditions
- Ischemic Stroke
- Being tested
- it-hMSC, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
it-hMSCDrug
Single intravenous infusion of it-hMSC for ischemic stroke patients
PlaceboDrug
Single intravenous infusion of 1 ml/kg placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental: it-hMSC | Experimental | Single intravenous infusion of 0.5×10^6, 1×10^6, 2×10^6 it-hMSC/kg Receives: Drug: it-hMSC |
| Placebo-controlled: Placebo | Placebo comparator | Single intravenous infusion of 1 ml/kg placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after it-hMSC infusion.
Measured: 12 months
Secondary outcomes (5)
Modified Rankin Scale
The change from the baseline in Modified Rankin Scale will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.
The scale is divided into 7 degrees, from 0 (no deficit) to 6 (dead).
Measured: month 1, month 3, month 6, month 9, month 12
National Institute of Health stroke scale
The change from the baseline in National Institute of Health stroke scale will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.
The range of scores is from 0 (normal) to 42.
Measured: month 1, month 3, month 6, month 9, month 12
Mini-mental State Examination
The change from the baseline in Mini-mental State Examination will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.
The range of scores is from 0 to 30 (normal).
Measured: month 1, month 3, month 6, month 9, month 12
Barthel Index
The change from the baseline in Barthel Index will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.
The range of scores is from 0 to 100 (normal).
Measured: month 1, month 3, month 6, month 9, month 12
Geriatric Depression Scale
The change from the baseline in Geriatric Depression Scale will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.
The range of scores is from 0 (normal) to 10.
Measured: month 1, month 3, month 6, month 9, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start26 Apr 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Aug 2023 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590118
- Sponsor's protocol ID
- STCMSC-CT-001
- Status last verified
- Mar 2022
- First submitted
- 7 Sep 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Multicenter, Blind, Randomized, Placebo Controlled Single Injection of It-hMSC in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04590118
- Acronym / sponsor ID
- STCMSC-CT-001
- Conditions
- Ischemic Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 19 Oct 2020 (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 purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of single injection of it-hMSC in patients with ischemic stroke in a multicenter, blind, randomized, placebo controlled trial
Detailed description
Stroke is a leading cause of disability. According to the comprehensive standardized prevalence estimation in 2016, 12.42 million people older than 40 years in China are currently suffering from stroke or have ever suffered from stroke. The overall prevalence rate of stroke in China was 1,596 per 100,000 people in 2016, 4.6 times higher than the rate of 345.1 per 100,000 people in 2013 and 70% of the survivors have disabilities in varying degrees. In addition to rehabilitation therapy, there is no therapeutic drugs of remarkable curative effect for the treatment of ischemic stroke patients. The latest data show that the annual recurrence rate of ischemic stroke in China is as high as 17.7%.
Allogeneic mesenchymal stem cells have been used in many clinical studies for different diseases. In addition to differentiating into multiple cell types and promoting the recovery and repair of the brain by replacing damaged cells, mesenchymal stem cells also secrete cytokines and neurotrophic factors to support and stimulate the growth of other endogenous cells. Meanwhile, mesenchymal stem cells also have anti-inflammatory and immunomodulatory functions. These characteristics of mesenchymal stem cells provide a new therapy for the treatment of stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: it-hMSC | Experimental | Drug: it-hMSCSingle intravenous infusion of 0.5×10^6, 1×10^6, 2×10^6 it-hMSC/kg |
| Placebo-controlled: Placebo | Placebo comparator | Drug: PlaceboSingle intravenous infusion of 1 ml/kg placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 years or older.
- Clinical diagnosis of ischemic stroke for more than 6 months.
- Imaging findings suggestive of ischemic stroke with functional deficits at initial diagnosis and enrollment.
- Severe neurological impairment associated with the diagnosis of ischemic stroke that resulted in the subject needing assistance to walk or not being able to perform general daily activities independently.
- No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment.
Key exclusion criteria (12 listed)
- History of epilepsy.
- History of cancer.
- History of brain trauma and brain tumor.
- Positive for hepatitis B surface antigen, E antigen, E antibody, core antibody, hepatitis C, HIV or RPR.
- Myocardial infarction occurred within six months of study entry.
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 |
|---|---|---|
| it-hMSCSingle intravenous infusion of it-hMSC for ischemic stroke patients | Drug | Experimental: it-hMSC |
| PlaceboSingle intravenous infusion of 1 ml/kg placebo | Drug | Placebo-controlled: Placebo |
Primary outcome
Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after it-hMSC infusion.
Time frame: 12 months
5 secondary outcomes
Modified Rankin Scale
Time frame: month 1, month 3, month 6, month 9, month 12
National Institute of Health stroke scale
Time frame: month 1, month 3, month 6, month 9, month 12
Mini-mental State Examination
Time frame: month 1, month 3, month 6, month 9, month 12
Barthel Index
Time frame: month 1, month 3, month 6, month 9, month 12
Geriatric Depression Scale
Time frame: month 1, month 3, month 6, month 9, month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
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 it-hMSC in people with Ischemic Stroke, run by Jiuzhitang Maker (Beijing) Cell Technology 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 12 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after it-hMSC infusion. (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 31 Mar 2022.