Mesenchymal Stromal Cells for Ischemic Stroke

Ischemic Stroke Clinical Trial

— SAMCIS  

Official title:

SAfety of Mesenchymal Stromal Cells for Ischemic Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01922908
• Other study ID #: SAMCIS
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: August 6, 2013
• Last updated: April 16, 2018
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 83 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Biological:
• MSC Infusion
Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset
• Placebo Comparator
Normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sean Savitz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose (MTD) of IV MSCs		24 hours
Secondary	Improved functional outcome	as assessed by changes in mRS, NIHSS, Fugyl-Meyer and Barthel Index	1 year