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Mesenchymal Stromal Cells for Ischemic Stroke (SAMCIS)

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ClinicalTrials.gov Identifier: NCT01922908
Recruitment Status : Withdrawn (Plan to change the trial design)
First Posted : August 14, 2013
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sean Savitz, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to determine if mesenchymal stem cells given by IV is feasible and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose when given between 3-10 days after an ischemic stroke.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Biological: MSC Infusion Biological: Placebo Comparator Phase 1 Phase 2

Detailed Description:

This is a randomized, double-blind, placebo controlled study. . Approximately 48 subjects will be enrolled in the trial, undergo a real or SHAM MSC IV infusion and will be follow out to 1 year. There will potentially be 4 Cohorts with the dose escalation at a 3:1 randomization schedule

Objectives:

  • The primary hypothesis' are that intravenous administration of allogeneic bone marrow derived mesenchymal stem cells is feasible and safe in patients with recent ischemic stroke and to determine the maximum tolerated dose (MTD) of IV MSCs when administered sub-acutely between 3-10 days following ischemic stroke.
  • The secondary hypothesis is that allogeneic MSC transplantation will improve functional outcome after recent ischemic stroke.

Safety and clinical efficacy points to be evaluated at Day 7 clinic visit, Day 30, Day 60, Day 90, and Day 180. Primary outcome or Primary endpoint of the study is to define the safety or harm of the MSCs


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: SAfety of Mesenchymal Stromal Cells for Ischemic Stroke
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: MSC infusion
Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset
Biological: MSC Infusion
Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset

Placebo Comparator: SHAM infusion
Infusion of normal saline placebo
Biological: Placebo Comparator
Normal saline




Primary Outcome Measures :
  1. maximum tolerated dose (MTD) of IV MSCs [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Improved functional outcome [ Time Frame: 1 year ]
    as assessed by changes in mRS, NIHSS, Fugyl-Meyer and Barthel Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 83 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. acute ischemic stroke
  2. age 18 to 83 years
  3. post stroke mRS > 3
  4. NIHSS of 7-25
  5. Deficits on the total NIHSS can be lower than 7 provided the patients have moderate aphasia or visual loss (2 on the Best Language or Visual loss NIHSS subcomponent) *Criteria for mRS not used for this category of subjects
  6. Last seen normal st within 3-9 days prior to stroke. Time of onset for wake-up stroke will be defined as the time the patient woke up with symptoms.
  7. stem cell transplantation procedure must be performed between 3-10 days after stroke symptom onset

Exclusion Criteria:

  1. Ischemic stroke, primary hemorrhagic or traumatic lesion of the brain or myocardial infarction within past 30 days prior to current stroke.
  2. Mechanical heart valve
  3. Uncontrolled seizure disorder, defined as a seizure within the last 6 months
  4. Developmental delay
  5. Chronic kidney disease
  6. Hepatic disease or altered liver function
  7. Pulmonary disease
  8. Cancer within 5 years prior to study
  9. Prior immunosuppression, including chemotherapy within last 3 years
  10. Known HIV
  11. Uncorrected coagulopathy or severe anemia
  12. Pregnancy
  13. Unable to undergo MRI or CT scan
  14. Imaging shows clinically significant hemorrhage

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): NCT01922908


Sponsors and Collaborators
Sean Savitz
Investigators
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Principal Investigator: Sean Savitz, MD The University of Texas Health Science Center, Houston

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Responsible Party: Sean Savitz, Professor, Department of Neurology, Director, Stroke Program, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01922908     History of Changes
Other Study ID Numbers: SAMCIS
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Keywords provided by Sean Savitz, The University of Texas Health Science Center, Houston:
Ischemic
Stroke
Stem Cells
MSC
Allogeneic
Bone Marrow
Additional relevant MeSH terms:
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Stroke
Pathologic Processes
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia