Hemorrhagic StrokePhase 1NCT03371329
Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
A Phase 1 study testing MSC in people with Hemorrhagic Stroke and Intracerebral Hemorrhage, run by Mayo Clinic at 1 site in United States.
Trial summary
The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Stroke, Intracerebral Hemorrhage
- What is being tested?
- MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2017to 9 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of 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.
Read the detailed 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.
- Conditions
- Hemorrhagic Stroke, Intracerebral Hemorrhage
- Being tested
- MSC
- Keywords
- mesenchymal stem cell, stroke, intracerebral hemorrhage, cell therapy
- Medical subject headings
- Hemorrhagic Stroke, Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCBiological
bone marrow derived cultured MSC (mesenchymal stem cell)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start12 Dec 2017
- Primary completion9 Oct 2020
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic StrokeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation study
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abba C. Zubair, M.D., Ph.D., Mayo Clinic
- Investigators
- Abba C Zubair, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371329
- Sponsor's protocol ID
- 15-003524
- Status last verified
- Dec 2020
- First submitted
- 3 Nov 2017
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Durand NC, Kim HG, Patel VN, Turnbull MT, Siegel JL, Hodge DO, Tawk RG, Meschia JF, Freeman WD, Zubair AC. Mesenchymal Stem Cell Therapy in Acute Intracerebral Hemorrhage: A Dose-Escalation Safety and Tolerability Trial. Neurocrit Care. 2024 Aug;41(1):59-69. doi: 10.1007/s12028-023-01897-w. Epub 2023 Dec 19.
PubMed 38114796
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT03371329
- Acronym / sponsor ID
- 15-003524
- Conditions
- Hemorrhagic Stroke, Intracerebral Hemorrhage
- Keywords
- mesenchymal stem cell, stroke, intracerebral hemorrhage, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| Group 1 MSC dose .5 x 10^6/kg IV | Experimental | Biological: MSCIntravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for 3 participants. |
| Group 2 MSC dose 1 x 10^6/kg IV | Experimental | Biological: MSCIntravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10^6/kg for next 3 participants. |
| Group 3 MSC dose 2 x 10^6/kg IV | Experimental | Biological: MSCIntravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10^6/kg for next 3 participants. |
| Group 4 MSC dose 0.5 x 10^6/kg I | Experimental | Biological: MSCIntraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for final 3 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCbone marrow derived cultured MSC (mesenchymal stem cell) | Biological | 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 |
Primary outcome
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.
1 secondary outcome
Changes in neurological function test
Time frame: Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Derived from this study: PubMed 38114796Durand NC, Kim HG, Patel VN, Turnbull MT, Siegel JL, Hodge DO, Tawk RG, Meschia JF, Freeman WD, Zubair AC. Mesenchymal Stem Cell Therapy in Acute Intracerebral Hemorrhage: A Dose-Escalation Safety and Tolerability Trial. Neurocrit Care. 2024 Aug;41(1):59-69. doi: 10.1007/s12028-023-01897-w. Epub 2023 Dec 19.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abba C Zubair principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSC in people with Hemorrhagic Stroke and Intracerebral Hemorrhage, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.