Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

NCT03371329 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 15-003524
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemorrhagic Stroke; Intracerebral Hemorrhage

Keywords

mesenchymal stem cell; stroke; intracerebral hemorrhage; cell therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in neurological function test

  Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180

Study Arms (4)

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

EXPERIMENTAL

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

Biological: MSC

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

EXPERIMENTAL

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

Biological: MSC

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

EXPERIMENTAL

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

Biological: MSC

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

EXPERIMENTAL

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

Biological: MSC

Interventions

MSC BIOLOGICAL

bone marrow derived cultured MSC (mesenchymal stem cell)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hemorrhagic Stroke; Cerebral Hemorrhage; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abba C Zubair

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical Director

Model Details: Dose escalation study

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: December 13, 2017
• Study Start: December 12, 2017
• Primary Completion: October 9, 2020
• Study Completion: October 9, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)