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Trial record 66 of 221 for:    umbilical cord mesenchymal stem cells

Effect of Different Transplantation Time for Mesenchymal Stem Cells(MSCs) of Cerebral Infarction Patients

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ClinicalTrials.gov Identifier: NCT04093336
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai East Hospital

Brief Summary:

This is a placebo controlled, randomized, double blinded study including Phase 1 and Phase 2. Phase I study is a safety assessment and Phase 2 study is incline to assess effectiveness of MSCs. Potential subjects must be screened and consented before enrolled.

The primary objective of this study is to determine the effects of different time points for intravenous infusion of allogeneic human umbilical cord mesenchymal stem cells (HucMSCs or MSCs used in the following section) for patients with acute ischemic stroke. Eligible patients will receive a single dose of MSCs or placebo within 12 hours or 5-7days after stroke. Patients will be followed for 2 years post infusion for safety and efficacy (change in neurological symptoms and quality of life). Assessments will occur during transplantation and at 3,7, 14 days and1,3, 6, 12, 18 and 24 months after infusions of stem cells.


Condition or disease Intervention/treatment Phase
Infarction, Middle Cerebral Artery Infarction, Anterior Cerebral Artery Cerebral Infarction Stroke, Ischemic Acute Stroke Biological: human umbilical cord mesenchymal stem cells Biological: Placebo Other: standardized treatment Phase 1 Phase 2

Detailed Description:

In Phase 1 study, the eligible patients with acute cerebral infarction 5-7 days after onset will be randomized to MSCs group or control group and receive intravenous MSCs 2 x 10^6/kg or placebo as a single dose, respectively. Each group will enroll 10 patients and patients will be followed for 2 years to observe the adverse events and evaluate the safety of MSCs for acute ischemic stroke patients.

The safety and preliminary effectiveness of MSCs in the treatment of acute cerebral infarction will be summarized after all patients of Phase 1 study were followed for 3 months post infusion, and the report will be submit to the academic committee and the ethics committee to evaluate before approval to begin the Phase 2 study.

In Phase 2 study, 100 patients with acute infarction within 12 hours after onset or 5-7 days after onset will be enrolled and randomized to MSCs group or control group. Patients will have baseline laboratory examinations and cerebral image (MRI or CTP). Enrolled patients will receive intravenous infusion of 2*10^6/kg MSCs or placebo for a single dose and follow for 24 months to assess the adverse events, neurological functional recovery and quality of life.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo controlled, randomized, double blinded
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Transplantation Time for Human Umbilical Cord Mesenchymal Stem Cells(MSCs) on Prognosis of Acute Cerebral Infarction Patients
Estimated Study Start Date : September 20, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Arm Intervention/treatment
Active Comparator: MSCs group
The people in this group will receive intravenous MSCs 2 x 10^6/kg as a single dose and standardized treatment of acute ischemic stroke.
Biological: human umbilical cord mesenchymal stem cells
The MSCs was intravenous transplanted to acute cerebral infarction patients as a single dose.

Other: standardized treatment
standardized treatment

Placebo Comparator: control group
The people in this group will receive placebo and standardized treatment of acute ischemic stroke.
Biological: Placebo
Placebo

Other: standardized treatment
standardized treatment




Primary Outcome Measures :
  1. adverse events [ Time Frame: 24 months post transplantation ]
    include tumorigenesis, death, pulmonary embolism, allergy, newly cerebrovascular events and other adverse events to evaluate the safety of MSCs for acute ischemic stroke patients


Secondary Outcome Measures :
  1. the National Institutes of Health Stroke Scale (NIHSS) of 3 months [ Time Frame: 3 months post transplantation ]
    The NIHSS neurologic examination includes 15 individual elements that measure motor and sensory function, language and speech production, vision, level of consciousness and attention, and neglect. The scores of each element are summed (range from 0 to 42) to evaluate the severity of neurological deficits. The more higher score means the more severe neurological dysfunction.

  2. the Barthel index (BI) of 3 months [ Time Frame: 3 months post transplantation ]
    The BI (range from 0 to 100) are used to assess the difference of activities of daily living between two groups. the score ≤40 means severe dependence, score 41~60 means moderate dependence, score 61~99 means mild dependence and score 100 means independence.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute ischemic stroke;
  2. Age 18~80y;
  3. 4≤NIHSS score≤18(including limb score≥2)and modified Rankin scale 0-1 before this cerebral ischemic stroke;
  4. patients and their families understand and will cooperate within the whole process of study, and sign informed consent;
  5. any of following items:①cerebral infarction in the internal carotid artery territory confirmed by cerebral CT perfusion < 12 hours after onset or ②cerebral infarction in the internal carotid artery territory confirmed by cerebral MR image 5 to 7 days after onset.

Exclusion Criteria:

  1. cardiogenic embolism by TOAST classification;
  2. accompanied by hematological disease, severe infection, liver dysfunction (ALT>3*ULN), kidney dysfunction (Scr >2*ULN), cardiac dysfunction (NYHA grade III or IV);
  3. Disturbance of consciousness, mental illness, cognitive impairment and other diseases that may affect informed consent and evaluation of study.
  4. Malignancy history or found to associate cancer after this stroke
  5. Pregnant or lactating women, or women have fertility requirements within 2 years;
  6. Accompanied by immunodeficiency diseases or autoimmune diseases;
  7. Life expectancy is less than 2 years;
  8. Participated in other clinical trial within 6 months;
  9. Patients received Chinese traditional medicine after onset of this stroke;
  10. Patients with allergic predisposition;
  11. Mental implantation or other reasons cannot tolerate magnetic resonance imaging;
  12. Cannot follow up regularly or unwilling to sign informed consent;
  13. Other situations not suitable for enrollment judged by the researchers;

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): NCT04093336


Contacts
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Contact: Gang Li, Doctor 0086-021-38804518-22106 ligang@tongji.edu.cn
Contact: Lian Zuo, Doctor 0086-021-38804518-22106 mizzmy@163.com

Locations
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China, Shanghai
Gang Li Recruiting
Shanghai, Shanghai, China, 200123
Contact: Gang Li, Doctor    0086-021-38804518-22106      
Sponsors and Collaborators
Shanghai East Hospital
Investigators
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Principal Investigator: Gang Li, Doctor Shanghai East Hospital

Publications of Results:

Other Publications:
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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT04093336     History of Changes
Other Study ID Numbers: 2018-DFSC-002
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shanghai East Hospital:
Acute cerebral infarction ,Mesenchymal Stem Cells,prognosis
Additional relevant MeSH terms:
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Pathologic Processes
Stroke
Cerebral Infarction
Infarction, Middle Cerebral Artery
Infarction, Anterior Cerebral Artery
Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Necrosis
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases