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Mesenchymal Stromal Cells for Ischemic Stroke (SAMCIS)

Primary Purpose

Ischemic Stroke

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MSC Infusion

Placebo Comparator

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic, Stroke, Stem Cells, MSC, Allogeneic, Bone Marrow

Eligibility Criteria

18 Years - 83 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

acute ischemic stroke
age 18 to 83 years
post stroke mRS > 3
NIHSS of 7-25
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
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.
stem cell transplantation procedure must be performed between 3-10 days after stroke symptom onset

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MSC infusion

SHAM infusion

Arm Description

Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset

Infusion of normal saline placebo

Outcomes

Primary Outcome Measures

maximum tolerated dose (MTD) of IV MSCs

Secondary Outcome Measures

Improved functional outcome

as assessed by changes in mRS, NIHSS, Fugyl-Meyer and Barthel Index

Full Information

NCT ID

NCT01922908

First Posted

August 6, 2013

Last Updated

April 16, 2018

Sponsor

Sean Savitz

1. Study Identification

Unique Protocol Identification Number

NCT01922908

Brief Title

Mesenchymal Stromal Cells for Ischemic Stroke

Acronym

SAMCIS

Official Title

SAfety of Mesenchymal Stromal Cells for Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Plan to change the trial design

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sean Savitz

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Ischemic, Stroke, Stem Cells, MSC, Allogeneic, Bone Marrow

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MSC infusion

Arm Type

Active Comparator

Arm Description

Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset

Arm Title

SHAM infusion

Arm Type

Placebo Comparator

Arm Description

Infusion of normal saline placebo

Intervention Type

Biological

Intervention Name(s)

MSC Infusion

Intervention Description

Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset

Intervention Type

Biological

Intervention Name(s)

Placebo Comparator

Intervention Description

Normal saline

Primary Outcome Measure Information:

Title

maximum tolerated dose (MTD) of IV MSCs

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Improved functional outcome

Description

as assessed by changes in mRS, NIHSS, Fugyl-Meyer and Barthel Index

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

83 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: acute ischemic stroke age 18 to 83 years post stroke mRS > 3 NIHSS of 7-25 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 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. stem cell transplantation procedure must be performed between 3-10 days after stroke symptom onset Exclusion Criteria: Ischemic stroke, primary hemorrhagic or traumatic lesion of the brain or myocardial infarction within past 30 days prior to current stroke. Mechanical heart valve Uncontrolled seizure disorder, defined as a seizure within the last 6 months Developmental delay Chronic kidney disease Hepatic disease or altered liver function Pulmonary disease Cancer within 5 years prior to study Prior immunosuppression, including chemotherapy within last 3 years Known HIV Uncorrected coagulopathy or severe anemia Pregnancy Unable to undergo MRI or CT scan Imaging shows clinically significant hemorrhage

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sean Savitz, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Mesenchymal Stromal Cells for Ischemic Stroke

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