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Completed

NCT Number: NCT03371329

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

MSC

Biological

bone marrow derived cultured MSC (mesenchymal stem cell)

Primary outcomes

  1. Occurrence of adverse events

    Time frame: 1 year

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

Secondary outcomes

  1. Changes in neurological function test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2017
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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