STEM-PD / Skane University Hospital, Lund University, Novo Nordisk, Cambridge University Hospitals NHS Foundation Trust - LARVOL DELTA

Human embryonic stem cell-derived dopaminergic cells for Parkinson's disease: a phase 1/2 open-label trial. (PubMed, Nat Med) - P1 | "Here we report the 12-month primary safety end point and interim efficacy outcomes from a phase 1/2, open-label, multicenter trial evaluating STEM-PD, a cryopreserved, off-the-shelf dopaminergic progenitor product derived from human pluripotent stem cells...Ongoing follow-up to 36 months will further evaluate durability, clinical outcomes and graft function. ClinicalTrials.gov identifier: NCT05635409 ."

Journal • P1/2 data • CNS Disorders • Infectious Disease • Movement Disorders • Oncology • Parkinson's Disease • Respiratory Diseases • Transplantation

STEM-PD: An open-label phase I/II trial of transplanted human pluripotent stem cell-derived dopaminergic progenitor cells in Parkinson’s disease (WPC 2026) - P1 | "Our results are in line with the data reported in several other recent trials of transplanted pluripotent-derived dopaminergic cell products. These findings support the continued development of this therapeutic approach, including evaluation of the STEM-PD product in larger patient cohorts."

Clinical • First-in-human • Late-breaking abstract • P1/2 data • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

Zuckerberg backed-Cellular Intelligence acquires Novo Nordisk's Parkinson's cell therapy (Reuters) - "Financial terms ​of the agreement were not disclosed. Novo will ​take an equity stake in Cellular and could ⁠receive future milestone payments and royalties, the biotech ​firm said; The treatment, named STEM-PD, an allogeneic, stem cell-derived therapy, designed to ​replace dopamine-producing nerve cells lost in Parkinson's disease...Cellular said it ​intends to apply its proprietary AI platform to speed ​up the treatment's development, scale manufacturing and reduce costs. The data will ‌be ⁠used to further train the AI model...Cellular Intelligence has raised ⁠more ​than $60 million from investors including Khosla ​Ventures and the Chan Zuckerberg Initiative, a philanthropic organisation founded by ​Zuckerberg."

Commercial • Parkinson's Disease

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. (PubMed, BMJ Open) - P1 | "Trial results will be published in peer-reviewed journals. NCT05635409."

Clinical protocol • First-in-human • Journal • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

STEM-PD: A Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Region Skane | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2027 ➔ Nov 2027

Enrollment closed • Trial completion date • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

Preclinical quality, safety, and efficacy of a human embryonic stem cell-derived product for the treatment of Parkinson's disease, STEM-PD. (PubMed, Cell Stem Cell) - "We further observed highly comparable efficacy results between two different GMP batches, verifying that the product can be serially manufactured. A fully in vivo-tested batch of STEM-PD is now being used in a clinical trial of 8 patients with moderate PD, initiated in 2022."

Journal • Preclinical • CNS Disorders • Movement Disorders • Oncology • Parkinson's Disease • Transplantation

STEM-PD: A Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Region Skane | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

Lund University : Swedish Medical Products Agency grants approval for clinical study of new stem cell based Parkinson’s Disease treatment (Market Screener) - "An investigational stem cell-based therapy for the treatment of Parkinson's Disease, STEM-PD, has been given regulatory approval for a Phase I/IIa clinical trial. Ethical approval of the trial has already been obtained from the Swedish Ethics Review Authority, and the STEM-PD team, led from Lund University in Sweden, is thereby ready to proceed with the trial....The STEM-PD trial is investigating the safety and tolerability of transplanting STEM-PD cells into the brain of patients with moderate Parkinson's disease...The primary outcome of the STEM-PD trial is to assess safety and tolerability of the transplanted product at 1-year post-transplantation, while secondary endpoints will assess survival and function of the transplanted cells by brain imaging, as well as measure effects on Parkinson's symptoms. The STEM-PD trial plans to enroll a total of 8 patients for transplantation..."

New P1/2 trial • CNS Disorders • Parkinson's Disease