Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
100 participants
INTERVENTIONAL
2023-12-01
2024-12-01
Brief Summary
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Detailed Description
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Focused ultrasound has been shown to enhance local blood flow and has been presented as a non-invasive means of targeting delivery of therapeutic agents.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment of Craniofacial Neuralgia
All patients will receive the same amount (5mL concentrated) of exosomes delivered via ultrasound-guided, regional epineural injection and the same amount (5mL unconcentrated) delivered via IV. Patients will be given 3 mL of the exosome product intravenously, which contains about 45mg of the exosome product containing 15-21 million neonatal stem cell products, and 3 mL of the exosome hyperconcentrate product delivered epineurally using ultrasound guidance, which contains about 15mg of the exosome product carrying 5-7 million neonatal stem cell products.
Exosomes
Focused ultrasound delivery of intravenously-infused exosomes
Interventions
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Exosomes
Focused ultrasound delivery of intravenously-infused exosomes
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of craniofacial neuralgia
Exclusion Criteria
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Recent surgery or dental work within 3 months of the scheduled procedure.
* Pregnancy, women who may become pregnant or are breastfeeding
* Advanced terminal illness
* Any active cancer or chemotherapy
* Bone marrow disorder
* Myeloproliferative disorder
* Sickle cell disease
* Primary pulmonary hypertension
* Immunocompromising conditions and/or immunosuppressive therapies
* Macular degeneration
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced kidney, pulmonary, cardiac or liver failure
* Subjects with vascular causes of dementia
* Bleeding disorder, untreated
18 Years
ALL
No
Sponsors
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Neurological Associates of West Los Angeles
OTHER
Responsible Party
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Principal Investigators
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Sheldon Jordan, MD
Role: PRINCIPAL_INVESTIGATOR
Neurological Associates of West Los Angeles
Locations
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Neurological Associates of West LA
Santa Monica, California, United States
Countries
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References
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Mikula I. [Craniofacial neuralgias]. Acta Med Croatica. 2008 May;62(2):163-72. Croatian.
Spina A, Mortini P, Alemanno F, Houdayer E, Iannaccone S. Trigeminal Neuralgia: Toward a Multimodal Approach. World Neurosurg. 2017 Jul;103:220-230. doi: 10.1016/j.wneu.2017.03.126. Epub 2017 Apr 2.
Rose FC. Trigeminal neuralgia. Arch Neurol. 1999 Sep;56(9):1163-4. doi: 10.1001/archneur.56.9.1163. No abstract available.
Cruccu G. Trigeminal Neuralgia. Continuum (Minneap Minn). 2017 Apr;23(2, Selected Topics in Outpatient Neurology):396-420. doi: 10.1212/CON.0000000000000451.
Maarbjerg S, Di Stefano G, Bendtsen L, Cruccu G. Trigeminal neuralgia - diagnosis and treatment. Cephalalgia. 2017 Jun;37(7):648-657. doi: 10.1177/0333102416687280. Epub 2017 Jan 11.
O'Neill F, Nurmikko T, Sommer C. Other facial neuralgias. Cephalalgia. 2017 Jun;37(7):658-669. doi: 10.1177/0333102417689995. Epub 2017 Jan 29.
Marchetti M, Pinzi V, De Martin E, Ghielmetti F, Fariselli L. Radiosurgery for trigeminal neuralgia: the state of art. Neurol Sci. 2019 May;40(Suppl 1):153-157. doi: 10.1007/s10072-019-03814-6.
Harding C, Heuser J, Stahl P. Receptor-mediated endocytosis of transferrin and recycling of the transferrin receptor in rat reticulocytes. J Cell Biol. 1983 Aug;97(2):329-39. doi: 10.1083/jcb.97.2.329.
Pan BT, Teng K, Wu C, Adam M, Johnstone RM. Electron microscopic evidence for externalization of the transferrin receptor in vesicular form in sheep reticulocytes. J Cell Biol. 1985 Sep;101(3):942-8. doi: 10.1083/jcb.101.3.942.
Johnstone RM, Adam M, Hammond JR, Orr L, Turbide C. Vesicle formation during reticulocyte maturation. Association of plasma membrane activities with released vesicles (exosomes). J Biol Chem. 1987 Jul 5;262(19):9412-20.
Bollini S, Gentili C, Tasso R, Cancedda R. The Regenerative Role of the Fetal and Adult Stem Cell Secretome. J Clin Med. 2013 Dec 17;2(4):302-27. doi: 10.3390/jcm2040302.
Balbi C, Piccoli M, Barile L, Papait A, Armirotti A, Principi E, Reverberi D, Pascucci L, Becherini P, Varesio L, Mogni M, Coviello D, Bandiera T, Pozzobon M, Cancedda R, Bollini S. First Characterization of Human Amniotic Fluid Stem Cell Extracellular Vesicles as a Powerful Paracrine Tool Endowed with Regenerative Potential. Stem Cells Transl Med. 2017 May;6(5):1340-1355. doi: 10.1002/sctm.16-0297. Epub 2017 Mar 8.
Zhang B, Yeo RW, Tan KH, Lim SK. Focus on Extracellular Vesicles: Therapeutic Potential of Stem Cell-Derived Extracellular Vesicles. Int J Mol Sci. 2016 Feb 6;17(2):174. doi: 10.3390/ijms17020174.
Other Identifiers
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ICSS-2019-019
Identifier Type: -
Identifier Source: org_study_id
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