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

Launched by THE FOUNDATION FOR ORTHOPAEDICS AND REGENERATIVE MEDICINE · Nov 29, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of using cultured stem cells derived from umbilical cords to treat two painful conditions: Trigeminal Neuralgia, which affects the face, and Peripheral Neuropathy, which impacts the nerves in the arms and legs. The researchers will give these stem cells through an intravenous infusion, meaning they will be delivered into the bloodstream. This is the first phase of the trial, and they are currently looking for participants.

To be eligible for this trial, individuals must have a diagnosis of either Trigeminal Neuralgia or Peripheral Neuropathy and be willing to sign a consent form that explains the study. However, those with certain health issues, like active infections, cancer, or serious organ problems, cannot participate. Participants will be monitored throughout the trial to ensure their safety and to see how well the treatment works. This study aims to gather important information that could help improve treatment options for these painful conditions in the future.

Gender

ALL

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