Phase 1 Parkinson's Disease Trial, Recruiting NCT07572071 Sponsor: Royan Institute Condition: Parkinson's Disease
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Phase 1 Parkinson's Disease Trial, Recruiting

NCT07572071
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 30 and 70 years old
  • You have been formally diagnosed with Parkinson's disease using recognised medical diagnostic criteria
  • You have had Parkinson's disease for more than 5 years
  • Your Parkinson's is at a moderate stage (Hoehn and Yahr stage 2 or 3 when your medication is not working, known as the "OFF" period) (confirm with trial site)
  • You are currently taking Parkinson's medication by mouth, but your symptoms are not well enough controlled, or you are having unwanted side effects from your current treatment
  • You have no history of, or only mild, involuntary movements caused by levodopa medication (confirm with trial site)
  • Your symptoms respond meaningfully when you take a proper dose of levodopa, as assessed by the trial doctor
  • Your blood test results meet specific requirements for white blood cells, platelets, liver function, and kidney function (confirm with trial site)
  • You are willing and able to give informed consent to take part

Who may not be able to join:

  • You have a condition that affects how your immune system works
  • A brain MRI scan has shown brain injuries such as shrinkage, stroke, trauma, or abnormal blood vessels
  • A specific brain scan (DaT SPECT) shows unusual results in a particular area of the brain (confirm with trial site)
  • Any other abnormal findings are found on your brain MRI scan
  • You test positive for a gene mutation called GBA
  • You have been diagnosed with dementia, shown by a memory and thinking test score below 24 (MoCA test)
  • You have a condition affecting blood clotting, or you are at high risk of bleeding
  • You test positive for certain viruses or active infections, including hepatitis B, hepatitis C, HIV, HTLV, syphilis, CMV, chickenpox virus, Epstein-Barr virus, or COVID-19
  • You are unable to have an MRI scan, for example because you have metal implants, a pacemaker, an MRI-incompatible artificial heart valve, severe claustrophobia, or your body weight is outside the range the MRI machine can accommodate
  • You have a known allergy or medical reason that prevents you from taking the study medications: Tacrolimus, Prednisolone, Basiliximab, Cotrimoxazole, or MRI contrast dye
  • You are currently receiving or have received another type of cell transplant, including stem cell treatments
  • You have or have had cancer, epilepsy, or bleeding in the brain alongside your Parkinson's disease
  • You have an uncontrolled or treatment-resistant psychiatric condition such as severe depression, bipolar disorder, or schizophrenia, confirmed by a psychiatrist
  • A psychiatrist has determined that you have an intellectual disability that prevents you from fully understanding what the study involves
  • You have previously had brain surgery for Parkinson's, such as pallidotomy, thalamotomy, or deep brain stimulation (DBS)
  • You are considered too high a risk for surgery due to significant heart, lung, or other serious health conditions
  • In the three months before joining, you have taken immunosuppressant drugs, antipsychotic medication, anti-seizure drugs, or blood thinners (unless safely stopped or adjusted); or in the six months before joining, you have received botulinum toxin injections, phenol injections, or similar treatments for muscle spasms
  • You have previously used a medication called Apomorphine for Parkinson's
  • You have a history of long-term heavy alcohol use or illegal drug use
  • You are pregnant, breastfeeding, or unwilling to use contraception during the study
  • The trial researchers have any other safety concerns about your participation (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 021-23562000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Royan Institute
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
1 August 2028

Where this trial is recruiting

Iran

Primary endpoints

Safety; Safety; Feasibility

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov