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| Name | Class |
|---|---|
| Kurve Technology Inc. | OTHER |
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This prospective observational study collects real world data on participants receiving regenerative therapies administered internationally and delivered intranasally via the Kurve Therapeutics ViaNase device. The study does not assign treatment. Participants are enrolled after receiving, or electing to receive, therapy as part of routine clinical care outside the study.
Participants are observed in one of three cohorts based on the therapy received: MuSE cell derived exosomes, MuSE stem cells, or combination therapy. The objective is to evaluate safety, tolerability, and changes in inflammatory biomarkers and clinical outcomes over time in a real world setting. The study also evaluates changes in inflammatory biomarkers, including serum tumor necrosis factor alpha (TNF-α), to better understand the biological effects of these therapies.
This is a prospective, multi cohort observational study designed to collect real world data on participants receiving regenerative therapies administered outside the study protocol and delivered intranasally via the Kurve Therapeutics ViaNase device.
The study does not assign interventions. Participants are enrolled after treatment decisions have been made by the treating clinician and patient as part of routine clinical care in international settings. Participants are categorized into observational cohorts based on the therapy received.
The study includes the following cohorts:
Cohort 1: Participants receiving 100 billion MuSE cell-derived exosomes administered intranasally via the ViaNase device Cohort 2: Participants receiving 50 million MuSE stem cells administered intranasally via the ViaNase device Cohort 3: Participants receiving combination therapy consisting of 100 billion MuSE cell-derived exosomes and 50 million MuSE stem cells administered intranasally via the ViaNase device
Dosing and treatment regimens are determined by the treating clinician and may vary based on individual patient factors and clinical protocols.
The primary objective is to characterize safety, tolerability, and changes in inflammatory biomarkers in a real world setting. Secondary objectives include evaluating trends in clinical outcomes, functional status, neurologic symptoms, and quality of life over time.
A key objective of this study is to evaluate changes in inflammatory biomarkers, including serum tumor necrosis factor alpha (TNF-α), measured at baseline and follow-up intervals. These biomarkers are used to explore the potential biological effects of intranasally delivered MuSE-derived therapies across treatment cohorts.
Data will be collected prospectively at baseline and predefined follow-up intervals, including approximately 1 month and 3 months post-treatment, using a combination of patient-reported outcomes, caregiver assessments, laboratory measurements, and available clinical documentation. Outcomes may include changes in functional performance, symptom burden, healthcare utilization, and biomarker levels.
This observational design enables the systematic collection of real-world evidence associated with internationally delivered regenerative therapies while maintaining separation between clinical care and research data collection.
Findings from this study may inform future controlled clinical trials and support hypothesis generation for regenerative medicine approaches targeting inflammatory and neurologic conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MuSE Cell Derived Exosomes | Participants in this observational cohort receive MuSE cell derived exosomes administered intranasally via the Kurve Therapeutics ViaNase system as part of routine clinical care outside the study protocol. The study does not assign treatment. Participants are followed prospectively to evaluate safety and tolerability and to assess changes in serum tumor necrosis factor alpha (TNF-α) as a biomarker of systemic inflammation. Exploratory outcomes include changes in neurologic function, symptom burden, and health-related quality of life over time. | ||
| MuSE Stem Cells | Participants in this observational cohort receive MuSE stem cells administered intranasally via the Kurve Therapeutics ViaNase system as part of routine clinical care outside the study protocol. The study does not assign treatment. Participants are followed prospectively to evaluate safety and tolerability and to assess changes in serum tumor necrosis factor alpha (TNF-α) as a biomarker of systemic inflammation. Exploratory outcomes include changes in neurologic function, symptom burden, and health-related quality of life over time. | ||
| Combination MuSE Exosomes Plus MuSE Stem Cells | Participants in this observational cohort receive combination therapy consisting of MuSE cell derived exosomes and MuSE stem cells administered intranasally via the Kurve Therapeutics ViaNase system as part of routine clinical care outside the study protocol. The study does not assign treatment. Participants are followed prospectively to evaluate safety and tolerability and to assess changes in serum tumor necrosis factor alpha (TNF-α) as a biomarker of systemic inflammation. Exploratory outcomes include changes in neurologic function, symptom burden, and health-related quality of life over time. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Tumor Necrosis Factor Alpha (TNF-α) From Baseline to 1 Month | Serum TNF-α concentration in pg/mL measured at baseline before treatment and at 1 month after treatment; analyzed as absolute and percent change from baseline within and across treatment cohorts. | Baseline to 1 Month |
| Incidence of Adverse Events | Number of participants with treatment-emergent adverse events after intranasal administration, categorized by seriousness, severity, and relationship to treatment as assessed from available clinical documentation. | Baseline to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum TNF-α From Baseline to 3 Months | Change in serum TNF-α concentration from baseline to 3 months following intranasal therapy, analyzed by treatment cohort. | Baseline to 3 Months |
| Caregiver or Participant Global Impression of Change |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gross Motor Function Measure-66 Score in Participants With Cerebral Palsy | Gross motor function will be assessed in participants with cerebral palsy using the GMFM-66. Items are scored on a 4-point ordinal scale and summarized as a total score; higher scores indicate better gross motor function. | Baseline to 3 Months |
Inclusion Criteria:
Exclusion Criteria:
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This study includes pediatric and adult participants with neurologic conditions receiving intranasal regenerative therapies administered outside the study protocol. Participants are enrolled into observational cohorts based on treatment type and followed prospectively to evaluate changes in inflammatory biomarkers, including TNF-α, as well as safety and clinical outcomes over time.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Glen Cronett, PhD/MD | Kurve Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem Solutions | Monterrey | Nuevo León | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41444595 | Background | Lu Z, Ren S, Wang B, Shao L, Zhang Y, Wu H, Mu X, Wang Z. Intranasally administered muse cells attenuate neurodegeneration in Parkinson's disease. J Transl Med. 2025 Dec 24;23(1):1421. doi: 10.1186/s12967-025-07401-6. | |
| 30484226 | Background | Perone MJ, Gimeno ML, Fuertes F. Immunomodulatory Properties and Potential Therapeutic Benefits of Muse Cells Administration in Diabetes. Adv Exp Med Biol. 2018;1103:115-129. doi: 10.1007/978-4-431-56847-6_6. |
| Label | URL |
|---|---|
| Kurve Therapeutics | View source |
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De identified individual participant data (IPD), including demographic information, treatment details, and outcome measures such as TNF-α levels and clinical assessments, may be shared with qualified researchers upon reasonable request. Data will be shared only after removal of all direct identifiers and in compliance with applicable privacy regulations.
Data access will be provided for purposes of scientific research, analysis, and publication, subject to approval by the study sponsor or designated review body. Additional documentation, including study protocol and statistical analysis plans, may be made available upon request.
No data will be shared that could compromise participant confidentiality or violate applicable regulatory or ethical standards.
Individual participant data and supporting documents will be made available beginning 6 months following completion of primary data collection and will remain available for a period of 5 years.
Access to de identified individual participant data will be provided to qualified researchers upon reasonable request. Requests must include a research proposal outlining the intended use of the data.
Access will be granted following review and approval by the study sponsor or designated review body and may require a data use agreement. Only de-identified data necessary for the approved research purpose will be shared.
Data will be provided in a secure manner that protects participant confidentiality and complies with applicable ethical and regulatory standards.
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Caregiver- or participant-reported overall change in condition compared with baseline using a 7 point global impression of change scale.
| Baseline to 3 Months |
| Change in Health Related Quality of Life | Change in health related quality of life from baseline using the Pediatric Quality of Life Inventory (PedsQL) for pediatric participants or a comparable age appropriate quality of life instrument for adult participants. | Baseline to 3 Months |
| Change in Diagnosis Specific Functional Outcome Measures | Change from baseline in diagnosis appropriate validated functional measures, including GMFM-66 for cerebral palsy, GOSE for traumatic brain injury, modified Rankin Scale for stroke, and other predefined condition-specific instruments where applicable. | Baseline to 3 Months |
| Change in Glasgow Outcome Scale-Extended Score in Participants With Traumatic Brain Injury |
Global disability and recovery will be assessed using the Glasgow Outcome Scale-Extended, an 8-level ordinal scale in which higher scores indicate better recovery. |
| Baseline to 3 Months |
| Change in Modified Rankin Scale Score in Participants With Stroke | Global disability will be assessed using the modified Rankin Scale, a 0 to 6 ordinal scale in which lower scores indicate less disability. | Baseline to 3 Months |
| 35324926 | Background | Yamada Y, Minatoguchi S, Baba S, Shibata S, Takashima S, Wakao S, Okura H, Dezawa M, Minatoguchi S. Human Muse cells reduce myocardial infarct size and improve cardiac function without causing arrythmias in a swine model of acute myocardial infarction. PLoS One. 2022 Mar 24;17(3):e0265347. doi: 10.1371/journal.pone.0265347. eCollection 2022. |
| 27999136 | Background | Uchida H, Niizuma K, Kushida Y, Wakao S, Tominaga T, Borlongan CV, Dezawa M. Human Muse Cells Reconstruct Neuronal Circuitry in Subacute Lacunar Stroke Model. Stroke. 2017 Feb;48(2):428-435. doi: 10.1161/STROKEAHA.116.014950. Epub 2016 Dec 20. |
| 37051701 | Background | Nagaoki T, Kumagai G, Nitobe Y, Sasaki A, Fujita T, Fukutoku T, Saruta K, Tsukuda M, Asari T, Wada K, Dezawa M, Ishibashi Y. Comparison of the Anti-Inflammatory Effects of Mouse Adipose- and Bone-Marrow-Derived Multilineage-Differentiating Stress-Enduring Cells in Acute-Phase Spinal Cord Injury. J Neurotrauma. 2023 Dec;40(23-24):2596-2609. doi: 10.1089/neu.2022.0470. Epub 2023 May 16. |
| 32811374 | Background | Park YJ, Niizuma K, Mokin M, Dezawa M, Borlongan CV. Cell-Based Therapy for Stroke: Musing With Muse Cells. Stroke. 2020 Sep;51(9):2854-2862. doi: 10.1161/STROKEAHA.120.030618. Epub 2020 Aug 19. |
| 28931784 | Background | Tanaka T, Nishigaki K, Minatoguchi S, Nawa T, Yamada Y, Kanamori H, Mikami A, Ushikoshi H, Kawasaki M, Dezawa M, Minatoguchi S. Mobilized Muse Cells After Acute Myocardial Infarction Predict Cardiac Function and Remodeling in the Chronic Phase. Circ J. 2018 Jan 25;82(2):561-571. doi: 10.1253/circj.CJ-17-0552. Epub 2017 Sep 20. |
| 27019988 | Background | Hori E, Hayakawa Y, Hayashi T, Hori S, Okamoto S, Shibata T, Kubo M, Horie Y, Sasahara M, Kuroda S. Mobilization of Pluripotent Multilineage-Differentiating Stress-Enduring Cells in Ischemic Stroke. J Stroke Cerebrovasc Dis. 2016 Jun;25(6):1473-81. doi: 10.1016/j.jstrokecerebrovasdis.2015.12.033. Epub 2016 Mar 24. |
| 23787896 | Background | Kuroda Y, Wakao S, Kitada M, Murakami T, Nojima M, Dezawa M. Isolation, culture and evaluation of multilineage-differentiating stress-enduring (Muse) cells. Nat Protoc. 2013;8(7):1391-415. doi: 10.1038/nprot.2013.076. Epub 2013 Jun 20. |
| 31826733 | Background | Abe T, Aburakawa D, Niizuma K, Iwabuchi N, Kajitani T, Wakao S, Kushida Y, Dezawa M, Borlongan CV, Tominaga T. Intravenously Transplanted Human Multilineage-Differentiating Stress-Enduring Cells Afford Brain Repair in a Mouse Lacunar Stroke Model. Stroke. 2020 Feb;51(2):601-611. doi: 10.1161/STROKEAHA.119.026589. Epub 2019 Dec 12. |
| 33222596 | Background | Suzuki T, Sato Y, Kushida Y, Tsuji M, Wakao S, Ueda K, Imai K, Iitani Y, Shimizu S, Hida H, Temma T, Saito S, Iida H, Mizuno M, Takahashi Y, Dezawa M, Borlongan CV, Hayakawa M. Intravenously delivered multilineage-differentiating stress enduring cells dampen excessive glutamate metabolism and microglial activation in experimental perinatal hypoxic ischemic encephalopathy. J Cereb Blood Flow Metab. 2021 Jul;41(7):1707-1720. doi: 10.1177/0271678X20972656. Epub 2020 Nov 22. |
| 36440014 | Background | Hori Y, Kitani T, Yanishi K, Suga T, Kogure M, Kusaba T, Kushida Y, Dezawa M, Matoba S. Intravenous administration of human Muse cells recovers blood flow in a mouse model of hindlimb ischemia. Front Cardiovasc Med. 2022 Nov 11;9:981088. doi: 10.3389/fcvm.2022.981088. eCollection 2022. |
| 34214874 | Background | Chen X, Yin XY, Zhao YY, Wang CC, Du P, Lu YC, Jin HB, Yang CC, Ying JL. Human Muse cells-derived neural precursor cells as the novel seed cells for the repair of spinal cord injury. Biochem Biophys Res Commun. 2021 Sep 3;568:103-109. doi: 10.1016/j.bbrc.2021.06.070. Epub 2021 Jun 30. |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D002547 | Cerebral Palsy |
| D020925 | Hypoxia-Ischemia, Brain |
| D009422 | Nervous System Diseases |
| D009103 | Multiple Sclerosis |
| D000544 | Alzheimer Disease |
| D010300 | Parkinson Disease |
| D020521 | Stroke |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001925 | Brain Damage, Chronic |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003704 | Dementia |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
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