Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371329
• Other study ID #: 15-003524
• Status: Completed
• Phase: Phase 1
• Start date: December 12, 2017
• Est. completion date: October 9, 2020

Study information

• Verified date: December 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 9, 2020
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hemorrhagic Stroke
• Intracerebral Hemorrhage

Intervention

Biological:
• MSC
bone marrow derived cultured MSC (mesenchymal stem cell)

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials