Mesenchymal Stromal Cells for Ischemic Stroke

NCT ID: NCT01922908

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-12-31

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

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MSC infusion

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

Group Type: ACTIVE_COMPARATOR

MSC Infusion

Intervention Type: BIOLOGICAL

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

SHAM infusion

Infusion of normal saline placebo

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: BIOLOGICAL

Normal saline

Interventions

MSC Infusion

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

Intervention Type: BIOLOGICAL

Placebo Comparator

Normal saline

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 83 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sean Savitz

OTHER

Sponsor Role: lead

Responsible Party

Sean Savitz

Professor, Department of Neurology, Director, Stroke Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sean Savitz, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Other Identifiers

SAMCIS

Identifier Type: -

Identifier Source: org_study_id