Clinical trial NCT01849887: Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke
Official title: Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Ischemic Stroke
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* 1. Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated, radiologically confirmed, and with either diameter \>15 mm or volume \> 4cc.
* 2. The index stroke has clinical deficits that are moderate-severe (NIHSS score 7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring, and was not associated with a concomitant STelevation myocardial infarction.
* 3. Age 18-80 years, inclusive
* 4. Reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy.

Exclusion Criteria:

* 1. No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2).
* 2. Females of child-bearing potential will be excluded unless (1) a negative urine pregnancy test is obtained and (2) the patient has been effectively using contraceptive method with known failure rate \<1 % for at least 90 days.
* 3. Lactating mothers
* 4. If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion.
* 5. Known allergy to penicillin or to fetal bovine serum
* 6. Active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse.
* 7. Any diagnosis that makes survival to 1-year post-stroke unlikely.
* 8. Participation in any other experimental therapeutic clinical trial concurrently or in the prior three months.
* 9. Contraindication to undergoing MRI scanning.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 1 month after transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
Study officials:
affiliation: Univ Calif Irvine
name: Steve Cramer, MD
role: PRINCIPAL_INVESTIGATOR
References: