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Clinical Plan of Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT04953663
Recruitment Status : Recruiting
First Posted : July 8, 2021
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Biological: it-hMSC Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 arms for phase 1, and 3 arms for pashe 2
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Arm Intervention/treatment
Experimental: Low dose group
0.5 × 10 ^ 6 / kg (body weight) of it-hMSC per person
Biological: it-hMSC
Different doses of it-hMSC

Experimental: Middle dose group
1 × 10 ^ 6 / kg (body weight) of it-hMSC per person
Biological: it-hMSC
Different doses of it-hMSC

Experimental: High dose group
2 × 10 ^ 6 / kg (body weight) of it-hMSC per person
Biological: it-hMSC
Different doses of it-hMSC

Experimental: Highest dose cell group
Highest dose of it-hMSC
Biological: it-hMSC
Different doses of it-hMSC

Experimental: Sub high dose cell group
Sub high dose of it-hMSC
Biological: it-hMSC
Different doses of it-hMSC

Placebo Comparator: placebo group
placebo
Biological: it-hMSC
Different doses of it-hMSC




Primary Outcome Measures :
  1. Adverse events and serious adverse events rate [ Time Frame: In 12 months ]
    Safety and tolerability of it-hMSC treatment

  2. Rate of clinical significant changes in laboratory [ Time Frame: In 12 months ]
    Safety and tolerability of it-hMSC treatment

  3. Rate of abnormal neurological physical examination results [ Time Frame: In 12 months ]
    Safety and tolerability of it-hMSC treatment

  4. Rate of imaging changes [ Time Frame: In 12 months ]
    Safety and tolerability of it-hMSC treatment


Secondary Outcome Measures :
  1. Change of NIHSS scores [ Time Frame: 1、3、6、9、12 months after treatment ]
    The improvement of neurological function was evaluated by neurological

  2. Change of BI scores [ Time Frame: 1、3、6、9、12 months after treatment ]
    The improvement of neurological function was evaluated by neurological

  3. Change of mRS scores [ Time Frame: 1、3、6、9、12 months after treatment ]
    The improvement of neurological function was evaluated by neurological

  4. Change of MMSE scores [ Time Frame: 1、3、6、9、12 months after treatment ]
    The improvement of neurological function was evaluated by neurological

  5. Change of GDS scores [ Time Frame: 1、3、6、9、12 months after treatment ]
    The improvement of neurological function was evaluated by neurological



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female ≥ 18 years old;
  2. The history showed that the last clinical diagnosis of ischemic stroke was more than 6 months;
  3. The results of MRI at the first diagnosis and at the time of selection indicated that there was ischemic stroke and dysfunction;
  4. There was no significant improvement in neurological function or functional defect 2 months before the study;
  5. 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;
  6. NIHSS score was 6-20;
  7. The life expectancy is more than 12 months;
  8. 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);
  9. 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;
  10. 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;
  11. 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.

Exclusion Criteria:

  1. History of epilepsy;
  2. History of tumor;
  3. History of brain tumor and brain trauma;
  4. 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.
  5. Myocardial infarction occurred within 6 months before the trial;
  6. 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;
  7. Imaging examination showed subarachnoid hemorrhage or intracerebral hemorrhage in the past 12 months;
  8. Participate in another study on the use of test drug or equipment within 3 months before treatment;
  9. Participated in other stem cell therapy related research;
  10. History of drug or alcohol abuse in the past year;
  11. 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;
  12. Allergic to cattle and pork products.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04953663


Locations
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China
Peking University Third Hospital Recruiting
Beijin, China
Contact: Dongsheng Fan    13701023871    dsfan@sina.com   
Sponsors and Collaborators
Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04953663    
Other Study ID Numbers: D2020093
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases