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Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT03371329
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Abba C. Zubair, M.D., Ph.D., Mayo Clinic

Brief Summary:
The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.

Condition or disease Intervention/treatment Phase
Hemorrhagic Stroke Intracerebral Hemorrhage Biological: MSC Phase 1

Detailed Description:

The overall clinical development strategy of this project is to conduct this Phase I dose escalation study entitled "A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients with Recent Intracerebral Hemorrhage". This study will be performed under this current IND application and will be limited to the proposed 12 subjects (3 IV and 1 IT dose groups).

In this application the investigators are proposing to evaluate safety and feasibility of allogeneic, bone marrow (BM) derived mesenchymal stem cells (MSC) to induce neuroregeneration, improve neurological function and alleviate inflammation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : December 12, 2020
Estimated Study Completion Date : December 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Group 1 MSC dose .5 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for 3 participants.
Biological: MSC
bone marrow derived cultured MSC (mesenchymal stem cell)

Experimental: Group 2 MSC dose 1 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10^6/kg for next 3 participants.
Biological: MSC
bone marrow derived cultured MSC (mesenchymal stem cell)

Experimental: Group 3 MSC dose 2 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10^6/kg for next 3 participants.
Biological: MSC
bone marrow derived cultured MSC (mesenchymal stem cell)

Experimental: Group 4 MSC dose 0.5 x 10^6/kg I
Intraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for final 3 participants.
Biological: MSC
bone marrow derived cultured MSC (mesenchymal stem cell)




Primary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: 1 year ]
    Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.


Secondary Outcome Measures :
  1. Changes in neurological function test [ Time Frame: Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180 ]
    The NIH Stroke Scale will be used to assess stroke-related neurologic deficits. A trained observer rates the patient's ability to perform tasks and answer questions. Ratings for each item are scored with 3 to 5 grades with 0 as normal.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Age range: 18 years or older
  • Gender: Male or female
  • Acute spontaneous supratentorial ICH documented by head CT with ICH Score between 2 - 4 inclusive
  • Stable ICH hematoma volume 60mL or less as measured by ABC2 method by 24-72hrs
  • Ability to be enrolled within 72 hours of onset of stroke symptoms
  • Ability to provide written personal or surrogate consent. Only subjects who have signed the ICF will be enrolled into the study. The ICF will include elements required by Mayo IRB and FDA in US 21CFR50.
  • Subject must have adequate renal function; creatinine <1.5g/dl.
  • Subject must be available for all specified assessments at the study site through the completion of the study.
  • Subject must provide written ICF and authorization for use of and disclosure of PHI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371329


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Veronica M Munet-Diaz    904-953-3375    munet-diaz.veronica@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Abba C Zubair Mayo Clinic

Additional Information:
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Responsible Party: Abba C. Zubair, M.D., Ph.D., medical Director, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03371329     History of Changes
Other Study ID Numbers: 15-003524
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abba C. Zubair, M.D., Ph.D., Mayo Clinic:
mesenchymal stem cell
stroke
intracerebral hemorrhage
cell therapy

Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases