Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 15-003524
    NCT ID: NCT03371329
    Sponsor Protocol Number: 15-003524

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion 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 24-72 hrs.
  • 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 elementsrequired by Mayo IRB and FDA in US21CFR50.
  • 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.
  • Minimally invasive neurosurgical (burrhole craniotomy or similar) neurosurgical (M.I.S.) ICH evacuation can be performed with either the NICO Brain path stereotactic system, or the Penumbra aspiration system if done within the first 72 hrs of ICH onset, or if the patient has symptomatic neurological deterioration from ICH mass effect within this timeframe.
  • Placement of an external ventricular catheter (EVD) is permissible and considered M.I.S. since placed through a frontal burrhole for symptomatic hydrocephalus and cerebrospinal fluid diversion and allowed separate on in addition to M.I.S for ICH removal.
  • For Treatment Group 4 only, standard of care placement of External Ventricular Drain.

Exclusion Criteria:

  • Deep coma defined as a 5 or lower on the Glasgow Coma Scale (GCS).
  • Open craniotomy neurosurgical evacuation of ICH.
  • Secondary ICH related to aneurysm, AVM, trauma, brain tumor, or oral anticoagulants other than Warfarin. Apixiban and Rivaroxaban-related ICH will be permitted if reversed with FDA- approved Andexxa per Mayo Pharmacy protocol, as well as dabigatran reversal with Pradaxabind. However, other novel anticoagulants (e.g., edoxaban) without an FDA approved specific antidote at this time will be excluded.
  • Pregnancy or breast-feeding.
  • Pre-existing disability defined as a pre-stroke modified Rankin scale >2a. Patients with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the MSC infusion or complete the study.
  • Evidence or history of malignancy in the last 5 years (history of basal cell carcinoma is permitted).
  • Evidence of liver dysfunction; liver profile showing alkaline phosphatase higher than 115 u/L, total bilirubin greater than 1.0 mg/dL, ALT greater than 55 units/L and AST greater than 48units/L.
  • Evidence of significant cardiac dysfunction.
  • Septicemia with high fever and hemodynamic instability.
  • Patients who received any experimental therapy (drug or biologic) for any indication within 3 months of the study enrollment.

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Abba Zubair, M.D., Ph.D.

Open for enrollment

Contact information:

Dana Kontras D.N.P., M.S.N., R.N., C.C.R.C.

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20379665

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