StrokePhase 1/2NCT04953663

Clinical Plan of Ischemic Stroke

A Phase 1/2 study testing it-hMSC in people with Stroke, run by Peking University Third Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: it-hMSC
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteChina
Study dates: 1 Jan 2021to 1 Jan 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

Male and female ≥ 18 years old;
The history showed that the last clinical diagnosis of ischemic stroke was more than 6 months;
The results of MRI at the first diagnosis and at the time of selection indicated that there was ischemic stroke and dysfunction;
There was no significant improvement in neurological function or functional defect 2 months before the study;
There is serious neurological dysfunction related to the diagnosis in Article 2, which leads to the subjects need the assistance of others to walk, or cannot complete the general activities of daily living independently;
NIHSS score was 6-20;

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The life expectancy is more than 12 months;
Before 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 drugs or anticoagulants (except prohibited cases);
Be able to understand and provide the signed informed consent, or ask the designated legal guardian or spouse to make the above decision voluntarily on behalf of the subjects;
It is reasonable to expect that patients will receive standard medical care for secondary prevention of ischemic stroke and participate in safety follow-up of all plans;
Organ function determined according to the following criteria:
Serum AST ≤ 2.5 × Upper normal limit (ULN);
Serum alanine aminotransferase (ALT) ≤ 2.5 × Normal upper limit;
Total serum bilirubin ≤ 1.5 × Normal upper limit;
In subjects without antithrombotic therapy, prothrombin time (PT) and partial thrombokinase time (PTT) ≤ 1.25 × Normal upper limit;
Serum albumin ≥ 3.0g/dl;
Absolute neutrophil count (ANC) ≥ 1500/ μ L；
Platelets ≥ 150000/ μ L；
Hemoglobin ≥ 9.0g/dl;
Serum creatinine ≤ 1.5 × Normal upper limit;
Serum amylase or lipase were in normal range.

Who cannot join

History of epilepsy;
History of tumor;
History of brain tumor and brain trauma;
hepatitis B, five surface antigens, e antigens, e antibodies and core antibodies were positive for any one, positive for hepatitis C virus antibody, positive for syphilis serum antibody or HIV positive.
Myocardial infarction occurred within 6 months before the trial;
Suffering from any other medical disease with clinical significance, or with abnormal mental or laboratory results, the researcher or the sponsor determines that participating in the trial will bring safety risks to the subjects;

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Imaging examination showed subarachnoid hemorrhage or intracerebral hemorrhage in the past 12 months;
Participate in another study on the use of test drug or equipment within 3 months before treatment;
Participated in other stem cell therapy related research;
History of drug or alcohol abuse in the past year;
Women who are known to be pregnant, breast-feeding or have a positive pregnancy test (to be tested during the screening process) or plan to be pregnant during the trial;
Allergic to cattle and pork products.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

Peking University Third Hospital
Beijin
Dongsheng Fan, 13701023871, dsfan@sina.com
Recruiting

Other trials in China

About this study

Official title: A Multicenter, Blind, Randomized, Placebo-controlled Phase I / IIA Study to Evaluate the Safety, Tolerability, and Initial Efficacy of a Single Injection of Ischemia Tolerant Human Allogeneic Bone Marrow Mesenchymal Stem Cells in Patients With Ischemic Stroke

Read the detailed description

Stroke is the main cause of adult health damage. 20% of stroke survivors need institutional care after 3 months, and up to 30% of them have severe or permanent disability. Stem cells are a kind of pluripotent cells with the ability of self replication. The self-renewal and differentiation characteristics of mesenchymal stem cells, as well as cytokine secretion effect and immune characteristics, provide the possibility for mesenchymal stem cells to treat ischemic stroke. After the infusion of mesenchymal stem cells, the secretion of soluble media including growth factors and cytokines may be the main mechanism of mesenchymal stem cells. The main purpose of this study was to evaluate the safety and tolerance of intravenous injection of ischemia tolerant human allogeneic bone marrow mesenchymal stem cells in patients with ischemic stroke. The secondary objective was to evaluate the clinical efficacy of ischemic tolerant human allogeneic bone marrow mesenchymal stem cells in the treatment of ischemic stroke patients with neurological dysfunction.

Conditions: Stroke
Being tested: it-hMSC
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

it-hMSCBiological
Different doses of it-hMSC

Study groups in NCT04953663
Study group	Role	What they receive
Low dose group	Experimental	0.5 × 10 ^ 6 / kg (body weight) of it-hMSC per person Receives: Biological: it-hMSC
Middle dose group	Experimental	1 × 10 ^ 6 / kg (body weight) of it-hMSC per person Receives: Biological: it-hMSC
High dose group	Experimental	2 × 10 ^ 6 / kg (body weight) of it-hMSC per person Receives: Biological: it-hMSC
Highest dose cell group	Experimental	Highest dose of it-hMSC Receives: Biological: it-hMSC
Sub high dose cell group	Experimental	Sub high dose of it-hMSC Receives: Biological: it-hMSC
placebo group	Placebo comparator	placebo Receives: Biological: it-hMSC

What is being measured

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

Adverse events and serious adverse events rate
Safety and tolerability of it-hMSC treatment
Measured: In 12 months
Rate of clinical significant changes in laboratory
Safety and tolerability of it-hMSC treatment
Measured: In 12 months
Rate of abnormal neurological physical examination results
Safety and tolerability of it-hMSC treatment
Measured: In 12 months
Rate of imaging changes
Safety and tolerability of it-hMSC treatment
Measured: In 12 months

Secondary outcomes (5)

Change of NIHSS scores
The improvement of neurological function was evaluated by neurological
Measured: 1、3、6、9、12 months after treatment
Change of BI scores
The improvement of neurological function was evaluated by neurological
Measured: 1、3、6、9、12 months after treatment
Change of mRS scores
The improvement of neurological function was evaluated by neurological
Measured: 1、3、6、9、12 months after treatment
Change of MMSE scores
The improvement of neurological function was evaluated by neurological
Measured: 1、3、6、9、12 months after treatment
Change of GDS scores
The improvement of neurological function was evaluated by neurological
Measured: 1、3、6、9、12 months after treatment

Timeline

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

1 Jan 20211 Jan 2023

First posted8 Jul 2021
Study start1 Jan 2021
Primary completion1 Jan 2022 (estimated)
Study completion1 Jan 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by Peking University Third HospitalThe sponsor's other registered studies.
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
Model description: 3 arms for phase 1, and 3 arms for pashe 2
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04953663
Sponsor's protocol ID: D2020093
Status last verified: Jun 2021
First submitted: 27 Jun 2021
Last updated: 8 Jul 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Blind, Randomized, Placebo-controlled Phase I / IIA Study to Evaluate the Safety, Tolerability, and Initial Efficacy of a Single Injection of Ischemia Tolerant Human Allogeneic Bone Marrow Mesenchymal Stem Cells in Patients With Ischemic Stroke
ClinicalTrials.gov ID: NCT04953663
Acronym / sponsor ID: D2020093
Conditions: Stroke
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Peking University Third HospitalUniversity, hospital or other
Study start: 1 Jan 2021 (actual)
Primary completion: 1 Jan 2022 (estimated)
Study completion: 1 Jan 2023 (estimated)
First posted: 8 Jul 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6
Model description: 3 arms for phase 1, and 3 arms for pashe 2

Arm	Type	Receives
Low dose group	Experimental	Biological: it-hMSC0.5 × 10 ^ 6 / kg (body weight) of it-hMSC per person
Middle dose group	Experimental	Biological: it-hMSC1 × 10 ^ 6 / kg (body weight) of it-hMSC per person
High dose group	Experimental	Biological: it-hMSC2 × 10 ^ 6 / kg (body weight) of it-hMSC per person
Highest dose cell group	Experimental	Biological: it-hMSCHighest dose of it-hMSC
Sub high dose cell group	Experimental	Biological: it-hMSCSub high dose of it-hMSC
placebo group	Placebo comparator	Biological: it-hMSCplacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Male and female ≥ 18 years old;
The history showed that the last clinical diagnosis of ischemic stroke was more than 6 months;
The results of MRI at the first diagnosis and at the time of selection indicated that there was ischemic stroke and dysfunction;
There was no significant improvement in neurological function or functional defect 2 months before the study;
There is serious neurological dysfunction related to the diagnosis in Article 2, which leads to the subjects need the assistance of others to walk, or cannot complete the general activities of daily living independently;

Key exclusion criteria (12 listed)

History of epilepsy;
History of tumor;
History of brain tumor and brain trauma;
hepatitis B, five surface antigens, e antigens, e antibodies and core antibodies were positive for any one, positive for hepatitis C virus antibody, positive for syphilis serum antibody or HIV positive.
Myocardial infarction occurred within 6 months before the trial;

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-hMSCDifferent doses of it-hMSC	Biological	High dose group, Highest dose cell group, Low dose group, Middle dose group, Sub high dose cell group, placebo group

Primary outcome

Adverse events and serious adverse events rate
Time frame: In 12 months
Safety and tolerability of it-hMSC treatment
Rate of clinical significant changes in laboratory
Time frame: In 12 months
Safety and tolerability of it-hMSC treatment
Rate of abnormal neurological physical examination results
Time frame: In 12 months
Safety and tolerability of it-hMSC treatment
Rate of imaging changes
Time frame: In 12 months
Safety and tolerability of it-hMSC treatment

5 secondary outcomes

Change of NIHSS scores
Time frame: 1、3、6、9、12 months after treatment
Change of BI scores
Time frame: 1、3、6、9、12 months after treatment
Change of mRS scores
Time frame: 1、3、6、9、12 months after treatment
Change of MMSE scores
Time frame: 1、3、6、9、12 months after treatment
Change of GDS scores
Time frame: 1、3、6、9、12 months after treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke

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.

Peking University Third Hospital

Beijin, China

13701023871

dsfan@sina.com

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 Stroke, run by Peking University Third Hospital 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 21 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 8 Jul 2021. 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?

Adverse events and serious adverse events rate (time frame: In 12 months). The study lists 4 primary outcomes in all. 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 NCT04953663.

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 8 Jul 2021.