Mesenchymal Stromal Cells for Ischemic Stroke

Phase 1

Withdrawn

• Conditions: Ischemic Stroke
• Interventions: Biological: Placebo Comparator; Biological: MSC Infusion

• Registration Number: NCT01922908
• Lead Sponsor: Sean Savitz

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

Study Timeline

• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-14
• Study Start: 2016-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM infusion	Placebo Comparator	Infusion of normal saline placebo
MSC infusion	MSC Infusion	Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset

Primary Outcome Measures

Name	Time	Method
maximum tolerated dose (MTD) of IV MSCs	24 hours

Secondary Outcome Measures

Name	Time	Method
Improved functional outcome	1 year	as assessed by changes in mRS, NIHSS, Fugyl-Meyer and Barthel Index