Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- No age limits stated
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether nose drops containing exosomes are safe and help treat Parkinson's disease. Exosomes are tiny particles from donor stem cells taken from umbilical cord or placenta tissue. The study is for people with Parkinson's disease.
This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for the treatment of Parkinson's Disease
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have Parkinson's disease.
- Understand the study and be willing to sign a form agreeing to take part.
Who can't join
- Have an active infection or cancer.
- Have long-term failure of several organs, or have had an organ transplant.
- Are pregnant, or are a woman who has not gone through menopause and is not using birth control.
- Have important abnormal results on lab tests before treatment.
- Have a health problem that the study doctor thinks would make taking part unsafe.
- Have ongoing drug abuse.
- Have an allergy to sulfur.
- Take blood-thinning medicine.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Diagnosis of Parkinson's Disease * 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 * Anticoagulation medicine use
Study sites (1)
FL
- Prodromos Stem Cell Institute · Naples, FL 34102Chadwick Prodromos, MD · Study contact · 847-699-6810 ext. 202 · care@thepsci.comMore trials in Naples