Stem cells injected into brain to fight Parkinson's
NCT ID NCT05635409
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This first-in-human trial tests a stem cell therapy called STEM-PD for Parkinson's disease. Eight participants with moderate Parkinson's will have dopamine-producing cells transplanted into a brain region affected by the disease. The main goal is to check safety over 12 months, with follow-up for 3 years. Researchers also look for early signs that the treatment might improve symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STEM-PD product (dopaminergic progenitor cells from human embryonic stem cells)
- What this could lead to
- If it works, this could point toward a treatment that repairs damaged brain cells in Parkinson's disease, potentially reducing the need for daily medication.
- What could go wrong
- This is a very early, small trial (8 people) focused on safety, not effectiveness. The stem cells may not survive or could cause side effects like brain swelling or abnormal growths.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * Tremor dominant disease, as assessed by the PI or other delegated clinician * 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 * 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 * Any contraindication to neurosurgery * Unable to be imaged using MRI * Extensive ventral striatal loss or normal findings on F-DOPA PET at screening * Significant cognitive impairment indicative of an incipient dementia/established dementia or values consistent with MoCA score of ≤ 24 * Unable to perform normal copying of interlocking pentagons and/or a semantic fluency score for naming animals of less than 20 over 90 seconds * 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 * Severely reduced TPMT activity (less than half of the lower normal TPMT activity level) * History of documented severe/significant allergy requiring treatment * Female who is pregnant or breastfeeding * 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 * Female of childbearing potential or male unwilling to follow contraception requirements (see protocol section 12.15) * Any other condition which, in the opinion of the investigator, makes the patient inappropriate for entry into the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
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Region Skåne - Skåne University Hospital
Lund, 214 28, Sweden
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