Back to resultsAllogeneic Mesenchymal Stem Cells for the Survivors of Ischemic Stroke Trial (ASSIST)
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
it-hMSC
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental: it-hMSC
Placebo-controlled: Placebo
Arm Description
Single intravenous infusion of 0.5×10^6, 1×10^6, 2×10^6 it-hMSC/kg
Single intravenous infusion of 1 ml/kg placebo
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after it-hMSC infusion.
Secondary Outcome Measures
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).
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.
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).
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).
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.
Full Information
NCT ID
NCT04590118
First Posted
September 7, 2020
Last Updated
March 28, 2022
Sponsor
Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.
Collaborators
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04590118
Brief Title
Allogeneic Mesenchymal Stem Cells for the Survivors of Ischemic Stroke Trial (ASSIST)
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.
Collaborators
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
In phase I, the masking method is open-label, whereas in phase II, the masking method is double blind.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: it-hMSC
Arm Type
Experimental
Arm Description
Single intravenous infusion of 0.5×10^6, 1×10^6, 2×10^6 it-hMSC/kg
Arm Title
Placebo-controlled: Placebo
Arm Type
Placebo Comparator
Arm Description
Single intravenous infusion of 1 ml/kg placebo
Intervention Type
Drug
Intervention Name(s)
it-hMSC
Intervention Description
Single intravenous infusion of it-hMSC for ischemic stroke patients
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intravenous infusion of 1 ml/kg placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Modified Rankin Scale
Description
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).
Time Frame
month 1, month 3, month 6, month 9, month 12
Title
National Institute of Health stroke scale
Description
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.
Time Frame
month 1, month 3, month 6, month 9, month 12
Title
Mini-mental State Examination
Description
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).
Time Frame
month 1, month 3, month 6, month 9, month 12
Title
Barthel Index
Description
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).
Time Frame
month 1, month 3, month 6, month 9, month 12
Title
Geriatric Depression Scale
Description
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.
Time Frame
month 1, month 3, month 6, month 9, month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, MD
Phone
010-59978538
Email
yongjunwang1962@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Allogeneic Mesenchymal Stem Cells for the Survivors of Ischemic Stroke Trial (ASSIST)
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