Phase 2 Parkinson's Disease Trial, Not Yet Recruiting NCT07028632 Sponsor: iRegene Therapeutics Co., Ltd. Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Not Yet Recruiting

NCT07028632
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People aged between 50 and 75 years old, male or female.
  • People who are able to understand the purpose of the trial and sign a consent form agreeing to take part.
  • People who have been diagnosed with Parkinson's Disease according to recognised international diagnostic guidelines (2015), and have had Parkinson's Disease for at least 4 years.
  • People who are medically suitable for brain surgery under general anaesthetic, and who are able to have CT scans, MRI scans, and PET scans.
  • People whose Parkinson's symptoms during "off" periods (when medication is less effective) fall within a specific range of severity on a standard staging scale (Hoehn-Yahr stage 2.5 to 4) (confirm with trial site).
  • People whose movement symptoms score above 35 on a standard assessment during "off" periods, and who show a positive response to a levodopa challenge test (a test to see how well the body responds to Parkinson's medication) (confirm with trial site).
  • People who are currently taking levodopa medication but whose movement symptoms are not well controlled or whose medication has become less effective over time.
  • People who have been on a stable dose of Parkinson's medication for at least 4 weeks before joining the trial.
  • People whose blood and other laboratory test results are within acceptable ranges during the screening period and before any procedure.
  • People who agree to delay any other planned brain surgery, including deep brain stimulation (DBS), until after the 24-month follow-up period is complete.
  • People who agree not to take part in any other interventional clinical studies for 24 months after receiving the trial treatment.
  • People who agree not to receive any vaccines within 30 days after receiving the trial treatment.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose Parkinson's-like symptoms are caused by medications, metabolic conditions, or other underlying causes rather than Parkinson's Disease itself.
  • People who have previously had brain surgery related to Parkinson's Disease and are assessed by the investigator as posing significant risks, people with reasons they cannot have an MRI, people assessed as having any reason they should not have surgery or anaesthetic, or people who have had other surgeries that the investigator believes could affect their participation.
  • People whose brain CT or MRI scans show clear abnormalities.
  • People who have had a serious heart or cardiovascular condition within the year before screening.
  • People with a history of cancer, or who have received cell therapy or gene therapy within the five years before screening.
  • People who have had serious blood clotting problems or significant bleeding tendencies within 3 months before screening, or who are unable to temporarily stop blood-thinning or anti-clotting medications for at least 5 days before surgery.
  • People who have been using high-dose steroid medications or immune-suppressing medications long-term within 3 months before signing the consent form.
  • People with a history of mental illness who are assessed by the investigator as unsuitable to participate, or who have had thoughts of suicide or a suicide attempt within the past year or currently.
  • People who have received botulinum toxin (such as Botox) injections within 6 months before signing the consent form.
  • People with active epilepsy or who are currently taking anti-epilepsy medications.
  • People with a history of dementia or severe memory or thinking problems, or whose score on a specific dementia-related part of a standard Parkinson's assessment is above 3 during screening, or who cannot reliably keep a diary or sign a consent form due to dementia.
  • People with severe depression or severe anxiety at the time of screening.
  • People who have certain abnormal test results during screening, including abnormal blood clotting results, abnormal immune system test results assessed as unsuitable by the investigator, poorly controlled high blood pressure, severe drops in blood pressure when standing, or poorly controlled blood sugar in people with diabetes.
  • People who have other serious ongoing health conditions such as pulmonary heart disease, moderate to severe asthma, or severe chronic obstructive pulmonary disease (COPD).
  • People who have HIV, syphilis, active hepatitis C, active hepatitis B, active tuberculosis, or other active infections that the investigator believes could affect participation or the study results.
  • People with alcohol dependency or who test positive for illicit drug use.
  • People who have a known allergy or intolerance to any medications used in the study, including drugs in the macrolide class, or who have a history of significant allergies.
  • Women who could become pregnant and are not surgically sterilised, not post-menopausal, or not willing to use medically approved contraception for 2 years after receiving the trial treatment, and women who are currently breastfeeding; men who are not surgically sterilised or not willing to use medically approved contraception for 2 years after receiving the trial treatment.
  • People who have received electroconvulsive therapy (electric shock therapy) within 30 days before surgery.
  • People who are currently in another clinical trial, or who have taken part in another clinical study and received an intervention within 3 months before surgery.
  • People who experience severe involuntary movements (dyskinesia) in both their medicated "on" state and their unmedicated "off" state.

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 28 July 2026

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Phone: 0086-027-59337986

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
Not Yet Recruiting
Phase
Phase 2
Sponsor
iRegene Therapeutics Co., Ltd.
Registry
ClinicalTrials.gov
Start date
30 June 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Motor Function

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: 28 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