Printed from Voxsanity (voxsanity.com.au) — NCT07550374 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Parkinson's Disease Trial, Not Yet Recruiting
NCT07550374
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 18 to 70 years, of any gender.
- People who understand the study, are willing to follow its procedures, and have signed a consent form agreeing to take part.
- People who have been diagnosed with primary (non-secondary) Parkinson's disease according to recognised international diagnostic standards, and who have previously had deep brain stimulation (DBS) surgery or a surgical procedure to destroy a specific area of brain tissue involved in Parkinson's disease.
- People whose Parkinson's motor symptoms score at least 30 points on a standard rating scale when their DBS device is switched off and their medication is in the "off" state, and whose symptoms improve by at least 30% after taking a levodopa (a Parkinson's medication) test dose.
- People who are medically able to have brain surgery under general anaesthetic, and who are able to have CT, MRI, and PET scans.
- People who, at the screening visit with their DBS device switched on, are rated between stage 2.5 and 4 (inclusive) on a standard Parkinson's severity scale during their medication "off" state, and who experience at least 2 hours of "off" time per day with DBS switched on.
- People who have been taking their Parkinson's medications at stable doses for at least 4 weeks before receiving the study treatment.
- People whose blood test results during screening fall within acceptable ranges, including normal levels of white blood cells, neutrophils, and platelets, and acceptable measures of liver function, kidney function, and kidney filtration rate (confirm with trial site for exact values).
- People who agree to delay any other planned non-urgent brain surgery until after the 12-month follow-up period is complete.
- People who agree not to join any other interventional clinical trials for 12 months after receiving the study treatment.
- People who agree not to receive any vaccines for 30 days after receiving the study 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 parkinsonism has been confirmed by the investigating doctor to be caused by medications, a metabolic condition, or another underlying cause, rather than primary Parkinson's disease.
- People who have an ongoing infection, cerebrospinal fluid leak, or unhealed wound in the area of a previous brain surgery; a malfunctioning or displaced implanted device; a reason they cannot have an MRI (such as certain implants, cochlear implants, or a pacemaker/defibrillator); a medical reason they cannot have surgery or anaesthetic; or any other surgical concern the investigating doctor considers a risk to participation.
- People whose brain CT or MRI scans show significant abnormalities — such as blood vessel malformations, brain swelling, brain tumours, more than 10 small bleeds in the brain, or stroke damage in a specific brain region — that the investigating doctor judges to significantly increase the risk of surgery.
- People who have had a serious heart condition within the year before screening, such as severe heart failure, unstable chest pain, a heart attack, or significant heart rhythm problems, which the investigating doctor considers may increase surgical risk or make participation unsuitable.
- People with a history of a malignant (cancerous) tumour, or who have received any cell therapy or gene therapy within the 2 years before screening.
- People who have had active widespread blood clotting problems or a significant tendency to bleed in the 3 months before signing the consent form, or who are unable to stop taking blood-thinning or anti-clotting medications for at least 5 days before surgery.
- People who have used high-dose steroid medications (such as prednisone at 20 mg/day or more, or an equivalent dose of another steroid) or immune-suppressing medications continuously for 14 days or more within the 3 months before signing the consent form (not including creams or other topical treatments).
- People with a history of a psychiatric condition that the investigating doctor considers makes participation unsuitable, or who have had thoughts of suicide or a suicide attempt within the past year or currently.
- People who have received botulinum toxin (e.g. Botox) injections within the 6 months before signing the consent form.
- People who have active epilepsy or are currently taking anti-seizure medications at the time of screening.
- People with a history of dementia or severe memory and thinking problems; people who show clear signs of dementia or significant cognitive difficulty at screening; people who score more than 3 on the cognitive impairment section of a standard Parkinson's rating scale at screening; or people whose dementia means they are unable to accurately complete diaries or sign a consent form.
- People who have severe depression, severe anxiety, or severe difficulty swallowing at the time of screening.
- People whose screening blood tests show significant blood clotting problems, significant immune system abnormalities or autoimmune disease (as assessed by the investigating doctor), poorly controlled high blood pressure (above 160/100 mmHg despite treatment), severe drops in blood pressure when standing up, or poorly controlled diabetes (based on specific blood sugar measurements — confirm with trial site for exact values).
- People with other serious ongoing health conditions, such as severe lung disease causing significantly reduced lung function.
- People who have HIV infection, syphilis, active hepatitis C or hepatitis B, tuberculosis, or any other active infection the investigating doctor believes may affect participation or study results.
- People with alcohol dependence, or who test positive for drug misuse at screening.
- People who have a known allergy or contraindication to medications used in the study (such as tacrolimus or levodopa, or related drugs), or who have a history of allergic reactions to two or more different drugs or foods.
- Women who are able to become pregnant and have not had sterilisation surgery, are not post-menopausal, or are unwilling to use a medically recognised form of effective contraception for 2 years after receiving the study treatment; women who are currently breastfeeding; and men who have not had sterilisation surgery or who are unwilling to use effective contraception for 2 years after receiving the study treatment.
- People who have received electroconvulsive therapy (ECT) within the 30 days before receiving the study treatment.
- People who are currently in another clinical trial, or who took part in another interventional clinical study and received treatment within the 3 months before receiving the study treatment.
- People who experience severe involuntary movements (dyskinesia) during both their medication "on" and "off" states.
- People with a serious illness, people the investigating doctor considers unlikely to comply with the study requirements, or people with any other condition the investigating doctor believes may put them at risk or affect the study's results.
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.
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 1
Sponsor
iRegene Therapeutics Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
1 April 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Incidence and severity of Adverse Events as Assessed by CTCAE V5.0
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 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.