RecruitingPhase 1NCT05152394

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease


Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Enrollment

20 participants

Start Date

Aug 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Parkinson's Disease


Eligibility

Inclusion Criteria2

  • Diagnosis of Parkinson's Disease
  • Understanding and willingness to sign a written informed consent document

Exclusion Criteria11

  • 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
  • Anticoagulation medicine use

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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NCT05152394


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