Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Hemorrhagic Stroke; Intracerebral Hemorrhage

Treatments: Biological: MSC

Study type: Interventional

Funder types: Other

Identifiers

NCT03371329

15-003524

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: MSC

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

Experimental group

Description:

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

Treatment:

Biological: MSC

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

Experimental group

Description:

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

Treatment:

Biological: MSC

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

Experimental group

Description:

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

Treatment:

Biological: MSC