NCT05152368 Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells Exosomes for Trigeminal Neuralgia
| NCT ID | NCT05152368 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine |
| Condition | Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-09-09 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-09-09 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy * Understanding and willingness to sign a written informed consent document Exclusion Criteria: * 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
Contact & Investigator
Chadwick Prodromos, MD
PRINCIPAL INVESTIGATOR
The Foundation for Orthopaedics and Regenerative Medicine
Frequently Asked Questions
Who can join the NCT05152368 clinical trial?
This trial is open to participants of all sexes, studying Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05152368 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05152368 currently recruiting?
Yes, NCT05152368 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Foundation for Orthopaedics and Regenerative Medicine to inquire about joining.
Where is the NCT05152368 trial being conducted?
This trial is being conducted at St John's, Antigua and Barbuda.
Who is sponsoring the NCT05152368 clinical trial?
NCT05152368 is sponsored by The Foundation for Orthopaedics and Regenerative Medicine. The principal investigator is Chadwick Prodromos, MD at The Foundation for Orthopaedics and Regenerative Medicine. The trial plans to enroll 20 participants.