Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

Phase 1

Completed

• Conditions: Hemorrhagic Stroke; Intracerebral Hemorrhage
• Interventions: Biological: MSC

• Registration Number: NCT03371329
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-12-11
• Study Start: 2017-12-12
• Study First Posted: 2017-12-13
• Primary Completion: 2020-10-09
• Study Completion: 2020-10-09
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 3 MSC dose 2 x 10^6/kg IV	MSC	Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10\^6/kg for next 3 participants.
Group 1 MSC dose .5 x 10^6/kg IV	MSC	Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10\^6/kg for 3 participants.
Group 4 MSC dose 0.5 x 10^6/kg I	MSC	Intraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10\^6/kg for final 3 participants.
Group 2 MSC dose 1 x 10^6/kg IV	MSC	Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10\^6/kg for next 3 participants.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in neurological function test	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States