Neurology
CNS · motor neuron · perinatal
Muse cells have been studied in humans, in registered clinical trials. Between 2018 and 2024, published human trials of Muse cell-based preparations were conducted across six indications: subacute ischemic stroke, acute myocardial infarction, cervical spinal cord injury, neonatal hypoxic-ischemic encephalopathy, amyotrophic lateral sclerosis, and dystrophic epidermolysis bullosa [1–6]. Across the published research, donor-derived (allogenic) cells were administered intravenously without HLA matching and without immunosuppressive drugs [1–7].
ScrollThe heart. The first Muse cell product administered to humans — patients with acute myocardial infarction (heart attack).
The skin. Intravenous allogeneic Muse cells in adults with dystrophic epidermolysis bullosa.
Stroke. The program’s most rigorous study — a single IV dose in subacute ischemic stroke, reporting a significant treatment effect.
ALS. Safety and clinical effects of a Muse cell-based product in patients with amyotrophic lateral sclerosis.
The spinal cord. A single intravenous dose of allogenic Muse cells in cervical traumatic spinal cord injury.
Newborns. A Muse cell-based product in neonatal hypoxic-ischemic encephalopathy with therapeutic hypothermia.
The most rigorous study in the published program: a randomized, double-blind, placebo-controlled trial of CL2020, an allogenic Muse cell-based product, administered as a single intravenous dose to patients with subacute ischemic stroke [1]. The published results report a significant treatment effect compared with placebo. No HLA matching and no immunosuppression were used. PMID 37756573
The first human study of a Muse cell-based product: a first-in-human trial in patients with ST-elevation acute myocardial infarction, reporting on the safety and efficacy of intravenous administration [2]. PMID 32522904
A multicenter clinical trial of a single intravenous dose of allogenic Muse cells in patients with cervical traumatic spinal cord injury, reporting safety and feasibility [3]. PMID 39135172
A Phase 1 trial of a Muse cell-based product in newborns with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, reporting safety and tolerability [4]. PMID 39401019
A Phase 2 clinical trial of a Muse cell-based product in patients with ALS, reporting safety and clinical effects over the study period [5]. PMID 38014622
An open-label Phase 1/2 study of intravenous allogeneic Muse cells in adults with dystrophic epidermolysis bullosa [6]. PMID 33656198
Stroke: independence, measured. In the placebo-controlled stroke trial, 40% of treated patients reached functional independence within 12 weeks — four times the placebo rate — and approximately 70% within one year [1]. For a person rebuilding a life after a stroke, independence is the outcome that matters: dressing, walking, living at home.
In the same controlled trial, 24% of treated patients had gray hair turn black. Zero in the placebo group [1]. The study was designed to measure stroke recovery; the scalp was never the target. Findings like this are reported here for what they are: an observed result in a published controlled trial, and a reminder that intravenously delivered Muse cells reach the whole body — not only the site the physicians were watching.
Newborns: the SHIELD babies. The neonatal HIE trial enrolled newborns whose brains had been deprived of oxygen at birth — infants facing the possibility of lifelong ventilator dependence. The trial’s published finding is safety and tolerability [4].
“Every baby who received Muse cells has avoided mechanical ventilation — many developed normally and are attending kindergarten.”Mari DezawaDiscoverer of Muse cells · Tohoku University Attributed statement; reflects intravenous parent-cell clinical experience.
Spinal cord injury: function, not just safety. The cervical SCI trial’s published report describes improvements in neurological classification, activities of daily living, and quality-of-life measures across the study period, alongside its primary safety findings [3].
The heart: where human trials began. The first Muse cell product ever administered to humans was given to patients with acute myocardial infarction [2] — the program’s starting point, and an indication where follow-on work continues.
Every trial on this page studied verified material: enriched, SSEA-3-characterized Muse cell preparations, produced within the licensed chain that runs from the discovery at Tohoku University to the vial [1–7]. The published record — the safety profile, the administration without immunosuppression, the outcomes above — belongs to the patented Dezawa Method™ for creation of authentic muse cells and cannot be applied simply because a product uses the word “muse.”
Material sold under the Muse name that did not come through the licensed process is a different material, and the research on this page is not about it. Vendors working around MCI’s intellectual property have been observed to cite these same trials, but citing a study performed on one specific kind of cellular material does not make its findings true of another different material.
If you are a provider or patient seeking real muse cells, verify first.
The six published human trials are part of a much wider research program. Across twelve areas — from neurology and cardiology to hepatic, renal, pulmonary and longevity research — Muse cells are the subject of published clinical results, active and in-preparation studies, and preclinical work. The grid below labels each study: CLIN published clinical · PREP active or in preparation · PRE preclinical · EXP exploratory.
Neurology
CNS · motor neuron · perinatal
Cardiovascular
AMI · cardiometabolic
Skin & Wound Healing
EB · cornea · scarring
Orthopedics
SCI · joint · cartilage
Renal
CKD · FSGS · glomerular
Hepatic
regeneration · fibrosis
Pulmonary
IR injury · ARDS
Aesthetics
facial · split-face · skin
Longevity & Healthspan
aging · frailty · performance
Autoimmune & Immune Privilege
mechanism · inflammation
Translational & Multi-indication
cross-border · multi-program
Future Research Directions
additional indications
Immune privilege, non-tumorigenicity, and how Dezawa MuseCells® compare with conventional cell types, fully cited.
/safety Authentic Muse Cells — the paperDr. Joseph Purita’s paper on what authentic material is and why it matters. Free to download.
/library The full research libraryThe published literature, indexed — searchable by tier, indication and mechanism.
/research-hubMuse cell-based products are not approved by the FDA for any indication. Where treatment is offered, it is provided by licensed clinicians under the laws and regulations that apply in their state or jurisdiction.
The field’s larger trials are its current work. As new results publish, this page and the Research Hub are updated — with citations, or not at all.
Yes. Published human clinical trials of Muse cell-based preparations exist across six indications — subacute ischemic stroke, acute myocardial infarction, cervical spinal cord injury, neonatal hypoxic-ischemic encephalopathy, ALS and dystrophic epidermolysis bullosa [1–6] — including a randomized, placebo-controlled trial in stroke [1].
Subacute ischemic stroke, acute myocardial infarction, cervical spinal cord injury, neonatal hypoxic-ischemic encephalopathy, amyotrophic lateral sclerosis, and dystrophic epidermolysis bullosa [1–6]. Preclinical and in-preparation work spans additional areas, labeled by stage on this page. Findings are specific to each study’s protocol and population.
No. The published trials studied verified, SSEA-3-characterized preparations produced within the licensed chain [1–7]. Material that did not come through that chain is a different material, and the published findings are not evidence about it. Whether material is authentic Dezawa MuseCells® is verifiable directly: the provider appears on MuseCell Innovations’ authorized lists, or the supply is confirmed by MCI itself — see /how-to-verify-muse-cells.
The randomized, double-blind, placebo-controlled trial of muse cells in subacute ischemic stroke reported a significant treatment effect compared with placebo — 40% of treated patients functionally independent within 12 weeks, four times the placebo rate — from a single intravenous dose without HLA matching or immunosuppression [1].
No. muse cell products are not FDA-approved, and nothing on this page is a claim to diagnose, treat, cure or prevent any disease. The trials above are published clinical research; whether treatment is appropriate for any individual is a decision for a treating physician.
These products have not been evaluated or approved by the United States Food and Drug Administration (FDA) and are not intended to diagnose, treat, cure, or prevent any disease or medical condition. Any clinical use is at the sole discretion of a licensed healthcare provider and must comply with all applicable federal and state laws and regulations. Individual results may vary. No claims are made regarding safety or effectiveness for any specific clinical application.
The honest answer is: it depends on which cells, for what condition, in whose hands — and whether the material administered is the material that was studied. For Muse cell-based preparations specifically, published human trials exist across six indications, including a randomized placebo-controlled stroke trial reporting a significant treatment effect [1–6]. The boundaries matter as much as the results: findings belong to the conditions and protocols studied. This page lists every published trial with its citation.
For Muse cells, the published cartilage and osteochondral-repair work is preclinical — animal-model research, labeled PRE in the research map above. No published human Muse cell trial has studied cartilage regeneration. A field that tells you which evidence is preclinical is a field you can trust with your knee.