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A Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease

Study acronym: STEM-PD
StatusActive, Not Recruiting
PhasePhase 1
Started2022-11-30
View on ClinicalTrials.gov ↗

Amendment history

2025-12-09
Study Status, IPDSharing v6
Re-verified, no change to tracked fields
2024-11-13
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Completion date2027-06→2027-11
Study sitesdetails revised at 2 of 2 sites
2024-02-28
Study Status, Eligibility v4
Eligibility criteria+54 characters
[...] Moderate disease as defined by having Hoehn and Yahr stage ≤ 2-3 in OFF state Disease duration > 10 years Male or female, a [...] pre-formed specific anti-HLA antibodies to the cell product Severely reduced TPMT deficiencyactivity <(less 10than pmol/h/mghalf Hbof the lower normal TPMT activity level) History of documented severe/significant allergy requiring [...]
2023-06-28
Study Status, Eligibility v3
Eligibility criteria+30 characters
[...] ng Hoehn and Yahr stage ≤ 3 in OFF state Disease duration > 510 years Male or female, aged between 50 and 75 years (inclusi [...] 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 lea [...] r other delegated clinician at Cambridge/Lund, respectively Have received the full vaccination dose for COVID-19 as per local guidance, at least 3 weeks prior to consent Be approved by the TMG clinical sub-group for tr [...]
2023-02-14
Study Status v2
Start dateestimated 2022-12→confirmed 2022-11-30
2022-12-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 2 of 2 sites
2022-11-22
Original filing
Region Skane
146 trials monitored
See 5 trials at risk
Parkinson's Disease
1,423 trials monitored
See 59 trials at risk
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
Trial Details
NCT Number NCT05635409
Lead Sponsor Region Skane
Collaborators: Lund University, Cambridge University Hospitals NHS Foundation Trust, University of Cambridge
Conditions Parkinson Disease
Enrollment 8 participants
Start Date 2022-11-30
Primary Completion 2027-01 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2025-12-17