Clinical Plan of Ischemic Stroke

NCT04953663 | Unknown Phase 1

• 1 other identifier: D2020093
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Adverse events and serious adverse events rate

  Safety and tolerability of it-hMSC treatment

  In 12 months

• Rate of clinical significant changes in laboratory

  Safety and tolerability of it-hMSC treatment

  In 12 months

• Rate of abnormal neurological physical examination results

  Safety and tolerability of it-hMSC treatment

  In 12 months

• Rate of imaging changes

  Safety and tolerability of it-hMSC treatment

  In 12 months

Secondary Outcomes (5)

• Change of NIHSS scores

  1、3、6、9、12 months after treatment

• Change of BI scores

  1、3、6、9、12 months after treatment

• Change of mRS scores

  1、3、6、9、12 months after treatment

• Change of MMSE scores

  1、3、6、9、12 months after treatment

• Change of GDS scores

  1、3、6、9、12 months after treatment

Study Arms (6)

Low dose group

EXPERIMENTAL

0.5 × 10 \^ 6 / kg (body weight) of it-hMSC per person

Biological: it-hMSC

Middle dose group

EXPERIMENTAL

1 × 10 \^ 6 / kg (body weight) of it-hMSC per person

Biological: it-hMSC

High dose group

EXPERIMENTAL

2 × 10 \^ 6 / kg (body weight) of it-hMSC per person

Biological: it-hMSC

Highest dose cell group

EXPERIMENTAL

Highest dose of it-hMSC

Biological: it-hMSC

Sub high dose cell group

EXPERIMENTAL

Sub high dose of it-hMSC

Biological: it-hMSC

placebo group

PLACEBO COMPARATOR

placebo

Biological: it-hMSC

Interventions

it-hMSC BIOLOGICAL

Different doses of it-hMSC

High dose group; Highest dose cell group; Low dose group; Middle dose group; Sub high dose cell group; placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijin, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 arms for phase 1, and 3 arms for pashe 2

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 8, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)