Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
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ClinicalTrials.gov Identifier: NCT03371329 |
Recruitment Status :
Completed
First Posted : December 13, 2017
Last Update Posted : December 21, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemorrhagic Stroke Intracerebral Hemorrhage | Biological: MSC | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Dose escalation study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage |
Actual Study Start Date : | December 12, 2017 |
Actual Primary Completion Date : | October 9, 2020 |
Actual Study Completion Date : | October 9, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1 MSC dose .5 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for 3 participants.
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Biological: MSC
bone marrow derived cultured MSC (mesenchymal stem cell) |
Experimental: Group 2 MSC dose 1 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10^6/kg for next 3 participants.
|
Biological: MSC
bone marrow derived cultured MSC (mesenchymal stem cell) |
Experimental: Group 3 MSC dose 2 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10^6/kg for next 3 participants.
|
Biological: MSC
bone marrow derived cultured MSC (mesenchymal stem cell) |
Experimental: Group 4 MSC dose 0.5 x 10^6/kg I
Intraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for final 3 participants.
|
Biological: MSC
bone marrow derived cultured MSC (mesenchymal stem cell) |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371329
United States, Florida | |
Mayo Clinic in Florida | |
Jacksonville, Florida, United States, 32224 |
Principal Investigator: | Abba C Zubair | Mayo Clinic |
Responsible Party: | Abba C. Zubair, M.D., Ph.D., medical Director, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT03371329 |
Other Study ID Numbers: |
15-003524 |
First Posted: | December 13, 2017 Key Record Dates |
Last Update Posted: | December 21, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
mesenchymal stem cell stroke intracerebral hemorrhage cell therapy |
Hemorrhagic Stroke Stroke Pathologic Processes Cerebral Hemorrhage Hemorrhage Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Intracranial Hemorrhages |