Peripheral NeuropathyPhase 1NCT05152368
Safety of Cultured Allogeneic Adult Umbilical Cordor Placental Derived Stem Cells Exosomes for Trigeminal Neuralgia
A Phase 1 study testing cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes in people with Peripheral Neuropathy and Trigeminal Neuralgia, run by The Foundation for Orthopaedics and Regenerative Medicine at 2 sites in 2 countries.
Trial summary
This trial will study the safety and efficacy of instillation of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for the treatment of Trigeminal Neuralgia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Neuropathy, Trigeminal Neuralgia
- What is being tested?
- cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Sep 2022to Jan 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy
- Understanding and willingness to sign a written informed consent document
Who cannot join
- 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.
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- Continued drug abuse
- Pre-menopausal women not using contraception
- Previous organ transplant
- Hypersensitivity to sulfur
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Prodromos Stem Cell Institute
Naples, Florida, 34102
Chadwick Prodromos, MD, 847-699-6810 ext. 202, care@thepsci.com
Greece1 site, 1 recruiting
- Recruiting
Prodromos Stem Cell Institute
Athens
Chadwick Prodromos, MD, 847-699-6810 ext. 202, care@thepsci.com
About this study
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells Exosomes for the Treatment of Trigeminal Neuralgia
This trial will study the safety and efficacy of instillation of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for the treatment of Trigeminal Neuralgia.
Read the detailed description
This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell (MSCs) exosomes for the treatment of Trigeminal Neuralgia. Patients will receive an intranasal instillation of MSCs exosomes. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
- Conditions
- Peripheral Neuropathy, Trigeminal Neuralgia
- Being tested
- cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes
- Keywords
- Peripheral Neuropathy, Trigeminal Neuralgia, stem cell treatment
- Medical subject headings
- Peripheral Nervous System Diseases, Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomesBiological
cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Intranasal installation of exosomes Receives: Biological: cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events)
Clinical monitoring of possible adverse events or complications
Measured: Four year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start9 Sep 2022
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chadwick Prodromos, MD, Principal investigator, The Foundation for Orthopaedics and Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152368
- Sponsor's protocol ID
- ATG-1-MSC-019
- Status last verified
- Oct 2026
- First submitted
- 29 Nov 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No