Mesenchymal Stromal Cells for Ischemic Stroke

NCT01922908 | Withdrawn Phase 1

• 1 other identifier: SAMCIS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose (MTD) of IV MSCs

  24 hours

Secondary Outcomes (1)

• Improved functional outcome

  1 year

Study Arms (2)

MSC infusion

ACTIVE COMPARATOR

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

Biological: MSC Infusion

SHAM infusion

PLACEBO COMPARATOR

Infusion of normal saline placebo

Biological: Placebo Comparator

Interventions

MSC Infusion BIOLOGICAL

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

MSC infusion

Placebo Comparator BIOLOGICAL

Normal saline

SHAM infusion

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sean Savitz: lead

MeSH Terms

Conditions

Ischemic Stroke; Ischemia; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sean Savitz, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Neurology, Director, Stroke Program

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 14, 2013
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04