NCT05635409Active, not recruitingPhase 1
A Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease
STEM-PD Trial: A Multicentre, Single Arm, First in Human, Dose-escalation Trial, Investigating the Safety and Tolerability of Intraputamenal Transplantation of Human Embryonic Stem Cell Derived Dopaminergic Cells for Parkinson's Disease (STEM-PD Product)
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
Parkinson's disease (PD) occurs when an area of the brain begins to lose nerve cells that produce a chemical called dopamine. Dopamine is an important chemical, and one of its functions is that it helps to regulate body movement. The loss of these nerve cells leads to a reduction of dopamine in the brain. Medications used to treat PD temporarily replace this lost dopamine, but they do not repair the underlying disease. One of the most promising PD therapies to date has been the transplantation of dopamine producing cells into the brain. Unlike current treatments, these therapies may be able to repair the damage caused in PD. In this trial, the investigators will transplant a new stem cell therapy, called the STEM-PD product, into the area of the brain affected in people with PD. These stem cells can develop into many different cell types, including dopamine-producing nerve cells. The investigators will transplant the stem cells using a device that has been previously used for similar transplants in Lund. This is the first time that the STEM-PD product will be given to humans. The trial aims to assess whether the STEM-PD product is safe to use in people with PD. The investigators will also be looking for preliminary signs of efficacy. The trial will recruit participants with PD from the UK and Sweden. Eight participants will undergo the STEM-PD product transplant. Participants will receive a single dose of the STEM-PD product. Participants will attend for 25 visits primarily at their local recruiting hospital. For participants from the UK, some of the imaging will be performed at Invicro (London), and the surgery (including some visits before and after) and some imaging will be performed in Lund. All participants will be followed up for 36 months following surgery
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 15 Nov 2021
- Start date
- 30 Nov 2022
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Region Skane
- Diseases
- Parkinson disease
- NCT number
- NCT05635409
- EudraCT number
- 2021-001366-38
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 8
- From 30 Nov 2022 to the primary completion date, 31 Jan 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Significant drug induced dyskinesias as defined by a score of \> 2 in the Abnormal Involuntary Movement Scale (AIMS) dyskinesias rating scale, in any body part in the ON state
- Other concomitant treatment with neuroleptics (including atypical neuroleptics) and/or cholinesterase inhibitors
- Previous neurosurgery to the brain, or cell or organ transplantation, or recipient of repeated blood transfusions
- Any contraindication to immunosuppressive therapy, prophylactic antibiotics, and/or osteoporosis prophylaxis (refer to STEM-PD Trial Immunosuppressant Manual)
- High levels of pre-formed specific anti-HLA antibodies to the cell product
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks of the screening visit, or is currently enrolled in an interventional investigational trial
Other illness
- Tremor dominant disease, as assessed by the PI or other delegated clinician
- Ongoing major medical or psychiatric disorders, including depression (MADRS \> 20) and psychosis, that make participation unsuitable, as judged by the PI or other delegated clinician
- Significant cognitive impairment indicative of an incipient dementia/established dementia or values consistent with MoCA score of ≤ 24
- History of documented severe/significant allergy requiring treatment
- Any other condition which, in the opinion of the investigator, makes the patient inappropriate for entry into the trial
Other
- Any contraindication to neurosurgery
- Unable to be imaged using MRI
- Extensive ventral striatal loss or normal findings on F-DOPA PET at screening
- Unable to perform normal copying of interlocking pentagons and/or a semantic fluency score for naming animals of less than 20 over 90 seconds
- Severely reduced TPMT activity (less than half of the lower normal TPMT activity level)
- Female who is pregnant or breastfeeding
- Female of childbearing potential or male unwilling to follow contraception requirements (see protocol section 12.15)
Who the study is looking for
- Have given written informed consent to participate in the trial
- Diagnosed with PD as defined using Queens Square Brain Bank criteria
- Moderate disease as defined by having Hoehn and Yahr stage 2-3 in OFF state
- Disease duration \> 10 years
- Male or female, aged between 50 and 75 years (inclusive)
- Have a significant response to dopamine therapies as judged by the PI or other delegated clinician
- Have symptoms that are not appropriately controlled by existing oral anti-PD medications, as judged by the PI or other delegated clinician
- Ability to travel to Lund for surgery
- Followed up for at least 12 months prior to inclusion in this trial in the TransEUro observational study
- Be fluent in English/Swedish to enable completion of questionnaires as assessed by the PI or other delegated clinician at Cambridge/Lund, respectively
- Be approved by the TMG clinical sub-group for trial participation
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Region Skåne - Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
Related publications
- Human embryonic stem cell-derived dopaminergic cells for Parkinson's disease: a phase 1/2 open-label trial.Nat Med · 2026 · PMID 42426223
- STEM-PD trial protocol: a multi-centre, single-arm, first-in-human, dose-escalation trial, investigating the safety and tolerability of intraputamenal transplantation of human embryonic stem cell-derived dopaminergic cells for Parkinson's disease.BMJ Open · 2025 · PMID 41469040
This page is information, not medical advice. Discuss any trial with your doctor.