Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

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

Study Overview

• Status: Completed
• Conditions: Hemorrhagic Stroke; Intracerebral Hemorrhage
• Intervention / Treatment: Biological: MSC

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events	Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Abba C Zubair, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2017
• Primary Completion (ACTUAL): October 9, 2020
• Study Completion (ACTUAL): October 9, 2020

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (ACTUAL): December 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: stroke; intracerebral hemorrhage; cell therapy; mesenchymal stem cell
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hemorrhagic Stroke
• Other Study ID Numbers: 15-003524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No