A Phase 1 interventional study of MSC in Hemorrhagic Stroke and Intracerebral Hemorrhage, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
Among 76 studies in Hemorrhagic Stroke with a site in United States — 22 open to participants now, 28 under way, 1 of them phase 3. Hemorrhagic Stroke · United States.
Among the 76 studies in Hemorrhagic Stroke with a site in United States, this one is the 43rd largest by enrollment of the 57 interventional ones that give a count, is one of 5 that started in 2017, is one of 5 in phase 1, and was the 18th registered.
233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.
Browse Hemorrhagic Stroke studies →22 of the 76 studies in Hemorrhagic Stroke with a site in United States are open now. Recruiting first, the newest first:
Magnetic Tides · Sites in United States
Ages 18–80
University of Minnesota · Sites in United States
Ages 18+
phenox Inc. · Sites in United States
Ages 18+
Johns Hopkins University · Sites in United States
Ages 18+
Joyce Chen · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 62 Hemorrhagic Stroke studies recruiting now, 36 (58%) set no upper age limit and 7 (11%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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76 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 8 · Phase 3 3 · Phase 4 2
First in 2003; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 9 is below the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.
Median enrollment 30 across the 57 interventional studies, 300 across the 19 observational. Of the 45 that completed or were terminated, 17 (38%) have results posted.
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14 of 76 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 1 study filed under Hemorrhagic Stroke — fewer than ten, so there is no comparison to draw.
11 of the studies in Hemorrhagic Stroke with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07649135University of MinnesotaFeasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke | 2026-11-30 |
| NCT05085210Beth Israel Deaconess Medical CenterImproving Visual Field Deficits With Noninvasive Brain Stimulation | 2026-12 |
| NCT04534556Baylor Research InstituteWireless Nerve Stimulation Device To Enhance Recovery After Stroke | 2027-01-01 |
| NCT07053917Johns Hopkins UniversityPsychedelic Healing: Adjunct Therapy Harnessing Opened Malleability | 2027-02 |
| NCT07631078Magnetic TideskTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot | 2027-02-28 |
Add all 11 to your calendar (.ics) → With an account.
Among the 76 studies in Hemorrhagic Stroke with a site in United States, from their registry updates:
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The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.
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.
Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10\^6/kg for 3 participants.
Biological: MSC
Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10\^6/kg for next 3 participants.
Biological: MSC
Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10\^6/kg for next 3 participants.
Biological: MSC
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
Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.
Time frame: 1 year
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.
Time frame: Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180
Plan to share: No
Ran from Dec 2017 to primary completion in Oct 2020, 33 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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