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MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

About this Study

A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.

Sponsor Protocol ID:B01-04
IRB Number:2019-0020
Study Status:

Study Status

Actively Enrolling: The study is currently recruiting participants.

Closed for Enrollment: The study is not currently recruiting participants.

Closed for Enrollment
Study Type:

Study Type

Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.

Interventional
Study Phase:

Study Phase

Early Phase 1 Trials (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Phase 1 Trials: Trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.

Phase 2 Trials: Trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3 Trials: Trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Phase 4 Trials: Trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

Phase 3
Online Start Date:

Online Start Date

The online start date is the day that this trial first appeared on the UMMC website, which is not necessarily the day that the trial first began at UMMC.

June 28, 2023
Eligibility Criteria
Minimum Age

Age Requirement

Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.

18 years old
Maximum Age

Age Requirement

Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.

100 years old
Biological Sex

Biological Sex Requirement

Indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

 Both Male and Female
Cancer Related?

Cancer Related

Some studies may be targeted to cancer-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Pediatric Related?

Pediatric Related

Some studies may be targeted to child-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Indicates whether people who do not have the condition/disease being studied can participate in the clinical study.

Healthy volunteers play an important role in research because they help define "normal" ranges. While they may receive no direct benefit, healthy volunteers choose to participate in clinical research because they want to help others and contribute to advancing science.

No

Inclusion Criteria1. Male or female subjects 18 years of age or older; 

2. Clinical diagnosis of ischemic stroke involving cerebral cortex; 

o This inclusion criterion requires clinical signs that are consistent with imaging abnormalities required under inclusion criterion #5. Clinical diagnosis is defined as rapidly developed clinical signs of 1 or more focal (and potentially accompanying global) persistent disturbance(s) of cerebral function, with no apparent cause other than arterial occlusive ischemic stroke that involves cerebral cortex;

3. Onset of stroke symptoms must have occurred 18 to 36 hours prior to the planned start of administration of the investigational product; Note: Time of onset is defined as the time point, if known, when symptoms first began. For a stroke that occurred during sleep, or in an individual unable to report the time that symptoms began, the time of onset is defined as the time point when the subject was last observed to exhibit normal neurological function or was self-reported to have normal function; 

4. Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a National Institutes of Health Stroke Scale (NIHSS) score of 8 to 20 (inclusive) that does not change by 

4 points from the Screening to the Baseline assessment; Note: The Screening NIHSS score used for determination of eligibility should be collected as soon as possible following admission to the hospital, or in the event a subject receives concomitant reperfusion therapy, the subject’s Screening NIHSS score must be collected within 4 hours following completion of the last reperfusion (mechanical or pharmacologic) therapy; 

5. Confirmation of hemispheric cortical infarct by brain magnetic resonance imaging (MRI) or computed tomography (CT) demonstrating an acute ischemic infarct measuring 5 mL and 100 mL;

 6. A modified Rankin Scale (mRS) score of 0 or 1 prior to the onset of symptoms of the current stroke, by either self-reported history or by family/caregiver report; 

7. Female subjects must not be pregnant, breastfeeding, or planning on becoming pregnant during the study; and either: a. Not of childbearing potential, defined as one who has been postmenopausal for at least 1 year, or has been surgically sterilized; or b. Agree to use a medically accepted, effective method of avoiding pregnancy through the Day 90 Visit. Effective methods of contraception are defined as those that result in a low failure rate (

8. Male subjects with female sexual partners of childbearing potential must also agree to use an effective method of avoiding pregnancy through the Day 90 Visit; 

9. Subjects or legally authorized representatives (LARs) must freely sign the informed consent form after the nature of the study and the disclosure of his/her data have been explained; 

10. Willing and able to comply with all aspects of the treatment and testing schedule; and 

11. Willing and able to return to the study site for the post-treatment evaluations. 

Exclusion Criteria1. Presence of a lacunar or a brainstem infarct on MRI or CT as the etiology of current stroke symptoms;

2. Coma (score of 3 for item 1a of NIHSS); 

3. Occurrence of a hemorrhagic transformation of ischemic stroke as evidenced by brain MRI or CT that is clinically significant in the opinion of the Investigator; 

4. Fluctuation in neurologic status since the onset of stroke suggesting possible progression or expansion of stroke, transient ischemic attack, or stroke mimic; 

5. Onset of stroke >28 hours prior to the start of Screening; Note: Onset of stroke >28 hours prior to the start of Screening would not allow for administration of investigational product per protocol; 

6. Less than 6 hours between the Screening and Baseline NIHSS assessment; 

7. Initiation of intravenous (IV) tissue plasminogen activator (tPA) infusion >4.5 hours and/or mechanical reperfusion (MR) (defined as time of groin puncture) >8 hours after the onset of stroke; 

8. Plan to have a neurovascular procedure (e.g., carotid endarterectomy, stent placement, etc.) within the first year following stroke; 

9. Pre-existing ipsilateral focal neurologic deficits that would complicate evaluation; 

10. Seizure since the onset of stroke or prior history of seizures, with the exception of simple febrile seizures in childhood; 

11. Major neurologic event such as stroke or clinically significant head trauma in the 6 months preceding study entry; 

12. Uncontrolled hypertension prior to randomization, defined as persistent systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg despite antihypertensive therapy; 

13. Blood glucose level

Categories Click category to view its trials.
Stroke/Traumatic Brain Injury
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Margaret Smith
Phone Number: 601-815-8765
Email: mjsmith2@umc.edu
Principal Investigator:Sameer Sharma
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