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

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