RecruitingPhase 1NCT05152368

Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells Exosomes for Trigeminal Neuralgia

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells Exosomes for the Treatment of Trigeminal Neuralgia


Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Enrollment

20 participants

Start Date

Sep 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This trial will study the safety and efficacy of instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Trigeminal Neuralgia.


Eligibility

Inclusion Criteria2

  • Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy
  • Understanding and willingness to sign a written informed consent document

Exclusion Criteria10

  • Active infection
  • Active cancer
  • Chronic multisystem organ failure
  • Pregnancy
  • Clinically significant Abnormalities on pre-treatment laboratory evaluation
  • Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
  • Continued drug abuse
  • Pre-menopausal women not using contraception
  • Previous organ transplant
  • Hypersensitivity to sulfur

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Interventions

BIOLOGICALAlloEx

cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes


Locations(1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

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NCT05152368


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