TFG-001, A Novel 3D Neural Microtissue Cell Therapy, Demonstrates Superior Functionality and Reinnervation for Parkinson’s Disease

TreeFrog Therapeutics, a regenerative medicine biotech company developing next-generation cell therapies, today announced that it will present new preclinical data on TFG-001 at the 7th World Parkinson’s Conference. TFG-001, a 3D neural microtissue cell therapy, demonstrated rapid dopamine release and extensive graft-derived reinnervation across multiple advanced translational Parkinson’s disease models—supporting its potential as a best-in-class candidate.

The critical need for reinnervation in Parkinson's disease

In Parkinson's disease, an estimated 60–80% of dopaminergic neurons are already lost before motor symptoms even appear. The nigrostriatal pathway degenerates, destroying the essential wiring that connects dopamine-producing neurons to movement control. While chemical dopamine replacements (like levodopa) can manage symptoms, they cannot restore the spatial precision, feedback loops, or dynamic regulation of a healthy brain network.

To achieve true functional restoration, it is not enough to simply replace lost cells. Reinnervation must occur. This means the transplanted cells need to survive, mature, and extend new axons into the host tissue. TFG-001 has been engineered to conquer this biological challenge. Multiple non-clinical studies in the field have demonstrated that the extent of graft-derived reinnervation is a critical determinant of functional recovery in Parkinson’s disease animal models.

Professor Stephane Palfi, Professor of Neurosurgery, Head of the Neurosurgery Department at Henri Mondor Medical Center, Paris University (UPEC) commented, “These new results show robust, extensive reinnervation both in vitro and in vivo, across multiple preclinical models. I am looking forward to seeing the translation of these results into the clinic as the 3D aspect of iPSC derived neural microtissue has the potential to be a game-changer for the dopaminergic neural engraftment process and subsequent beneficial effect in Parkinson's disease.”

TFG-001 is designed to enhance post-transplantation integration and reinnervation. Unlike single-cell suspensions, which must re-establish connections with each other and the host tissue, its pre-organized 3D dopaminergic network, comprising both progenitors and neurons, facilitates more efficient integration and markedly improves reinnervation capacity.

Best-in-class characteristics of TFG-001:

• Rapid Dopamine Release: TFG-001 demonstrates dopamine release as early as 48 hours, versus ~28 days reported by benchmark cell therapies^i,ii
• Extensive Striatal Reinnervation: In vivo studies show that the graft successfully integrates and reinnervates target regions of the brain in the advanced translational Parkinson’s disease models.
• Accelerated Motor Recovery: Preclinical models achieved functional motor recovery in roughly 13 weeks, significantly faster than the 17–28 weeks reported by existing benchmark cell therapies ^{i,ii,iii, iv} (Piao et al., 2021; Hiramatsu et al., 2022; Kirkeby et al., 2023; Park et al., 2024).

Scalable manufacturing for a global patient need

Beyond its biological advantages, TFG-001 addresses some of the major manufacturing bottlenecks that have historically limited cell therapies. TFG-001 is manufactured using TreeFrog’s proprietary C-Stem™ platform, a closed, bioreactor-based system centered on capsule technology, designed for scalable cell expansion and differentiation under GMP-compliant conditions.

With approximately 1.3 million patients in the EU and 1.0 million in the US, the need for an effective, scalable regenerative therapy for Parkinson's disease is massive. TFG-001 will be ready for a Clinical Trial Application (CTA) in 2027.

TreeFrog Therapeutics is exploring co-development and commercialization of TFG-001.

To discuss the program further, please attend poster session 3:

Time / Date: Wednesday, May 27, 2026 –11:30AM – 1:30PM
Location: Hall D-E (3^rd floor) Poster Board: P02.03
Abstract title: Advancing neural microtissues toward a clinically viable cell therapy for Parkinson’s disease

About TreeFrog Therapeutics

TreeFrog Therapeutics is a French-based regenerative medicine biotech set to unlock access to cell therapies for millions of patients with a lead program in Parkinson’s disease. TreeFrog is unique in its approach to cell therapy development, bringing together biophysicists, cell biologists, and bioproduction engineers to address the challenges of the industry - producing and differentiating cells of quality at unprecedented scale, cost-effectively. To succeed in their mission of Cell Therapy for all, TreeFrog operates a business model that includes its own therapeutic programs and partnerships with leading biotech and industry players. Since 2021, the company has raised $82 million to advance a pipeline of stem cell-based therapies in regenerative medicine.

Learn more at treefrog.fr

ⁱ Hiramatsu, S. et al. Cryopreservation of Induced Pluripotent Stem Cell-Derived Dopaminergic Neurospheres for Clinical Application. JPD 12, 871–884. https://doi.org/10.3233/JPD-212934

ⁱⁱ Park, S. et al. Preclinical and dose-ranging assessment of hESC-derived dopaminergic progenitors for a clinical trial on Parkinson’s disease. Cell Stem Cell 31, 25-38.e8. https://doi.org/10.1016/j.stem.2023.11.009

ⁱⁱⁱPiao, J. et al. Preclinical Efficacy and Safety of a Human Embryonic Stem Cell-Derived Midbrain Dopamine Progenitor Product, MSK-DA01. Cell Stem Cell 28, 217-229.e7. https://doi.org/10.1016/j.stem.2021.01.004

^iv Kirkeby, A. et all Preclinical quality, safety, and efficacy of a human embryonic stem cell-derived product for the treatment of Parkinson’s disease, STEM-PD. Cell Stem Cell 30, 1299-1314.e9. https://doi.org/10.1016/j.stem.2023.08.014

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