search
Back to results

Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

Primary Purpose

Hemorrhagic Stroke, Intracerebral Hemorrhage

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MSC
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Stroke focused on measuring mesenchymal stem cell, stroke, intracerebral hemorrhage, cell therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1 MSC dose .5 x 10^6/kg IV

Group 2 MSC dose 1 x 10^6/kg IV

Group 3 MSC dose 2 x 10^6/kg IV

Group 4 MSC dose 0.5 x 10^6/kg I

Arm Description

Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for 3 participants.

Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10^6/kg for next 3 participants.

Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10^6/kg for next 3 participants.

Intraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for final 3 participants.

Outcomes

Primary Outcome Measures

Occurrence of adverse events
Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.

Secondary Outcome Measures

Changes in neurological function test
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.

Full Information

First Posted
November 3, 2017
Last Updated
December 17, 2020
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT03371329
Brief Title
Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
Official Title
Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
October 9, 2020 (Actual)
Study Completion Date
October 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Stroke, Intracerebral Hemorrhage
Keywords
mesenchymal stem cell, stroke, intracerebral hemorrhage, cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 MSC dose .5 x 10^6/kg IV
Arm Type
Experimental
Arm Description
Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for 3 participants.
Arm Title
Group 2 MSC dose 1 x 10^6/kg IV
Arm Type
Experimental
Arm Description
Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10^6/kg for next 3 participants.
Arm Title
Group 3 MSC dose 2 x 10^6/kg IV
Arm Type
Experimental
Arm Description
Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10^6/kg for next 3 participants.
Arm Title
Group 4 MSC dose 0.5 x 10^6/kg I
Arm Type
Experimental
Arm Description
Intraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for final 3 participants.
Intervention Type
Biological
Intervention Name(s)
MSC
Intervention Description
bone marrow derived cultured MSC (mesenchymal stem cell)
Primary Outcome Measure Information:
Title
Occurrence of adverse events
Description
Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in neurological function test
Description
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.
Time Frame
Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abba C Zubair
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

We'll reach out to this number within 24 hrs