InGeneron Publishes Landmark Study Demonstrating Structural Tendon Regeneration with Autologous Cell Therapy System

HOUSTON--(BUSINESS WIRE)--InGeneron, Inc., a biotechnology company pioneering autologous regenerative cell therapies, today announced the publication of a pivotal preclinical study in the International Journal of Molecular Sciences, further validating the regenerative mechanism of its proprietary cell therapy platform for tendon repair. The study, titled "Regeneration of Biomechanically Functional Tendon Tissue Following Injection of Uncultured, Autologous, Adipose-Derived Regenerative Cells [UA-ADRCs] into Partial Achilles Tendon Defects in Rabbits", provides robust evidence that InGeneron’s cell therapy restores functional tendon architecture, a key milestone in the company’s scientific narrative.

“This is the kind of disease-modifying evidence that regenerative medicine has promised but rarely delivered.”

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This publication completes a decade-long body of work establishing the full mechanism of action for InGeneron’s therapeutic approach. In contrast to other cell therapy players, InGeneron is now the only company to have validated every step of its therapeutic hypothesis through peer-reviewed data:

• Cell Characterization: Demonstrated consistent and reproducible cellular composition of ADRCs across age, sex, BMI, and ethnicity – Schmitz et al. Cells. 2023, 12, 30.
• In Vivo Regeneration: Proved functional tissue regeneration in animal models with histology and biomechanical testing, as shown in this newly published study – Schmitz et al. Int J Mol Sci. 2025;26(6800).
• Human Biopsy Evidence: Published first-in-human histological confirmation of tendon regeneration
  – Alt et al. World J Stem Cells. 2021;13(7):944–970.
• Clinical Trial Data: Showed statistically significant long-term pain and function improvements in partial-thickness rotator cuff tears
  – Hurd et al. J Orthop Surg Res. 2020;15(1):122. and Lundeen et al. Sci Rep. 13, 19348 (2023).

"This study confirms what we’ve set out to prove for years — that our therapy does not just alleviate symptoms, it restores tissue," said Dr. Eckhard Alt, Founder and Executive Chairman of InGeneron and senior author of the study. “This is the kind of disease-modifying evidence that regenerative medicine has promised but rarely delivered.”

In the controlled study, partial-thickness Achilles tendon defects were surgically created in rabbits and treated with either saline or a single injection of freshly isolated UA-ADRCs. Animals treated with UA-ADRCs showed:

• Newly formed, organized tendon-like tissue
• Histologic and immunohistochemical signatures of true tendon regeneration rather than scar formation
• Significantly improved biomechanical viscoelasticity compared to sham-treated animals

Co-author Dr. Nicola Maffulli, a globally recognized expert in tendon biology, added:

“We are delighted that our work has been published in a high-impact scientific journal. Tendon ailments affect millions of people, often compromising mobility and quality of life. Regenerative medicine has made bold promises in the past, but we now have strong evidence that this approach can truly heal tendon lesions. These seminal findings provide a scientific bridge to clinical applications, and with the support of InGeneron and our international research collaboration, we are confident that patients and athletes will benefit.”

The UA-ADRCs used in the study were isolated using InGeneron’s Transpose Ultra^® System, enabling same-day, point-of-care therapy. Unlike cultured or genetically modified therapies, InGeneron’s approach uses unmodified, freshly isolated autologous cells, preserving biological potency and improving safety.

Publication Details

Schmitz, C., Alt, C., Wuerfel, T., Milz, S., Dinzey, J., Hill, A., Sikes, K. J., Burton, L. H., Easley, J., Stewart, H. L., Puttlitz, C. M., Gadomski, B. C., Labus, K. M., Pearce, D. A., Maffulli, N., & Alt, E. U. (2025). Regeneration of Biomechanically Functional Tendon Tissue Following Injection of Uncultured, Autologous, Adipose-Derived Regenerative Cells into Partial Achilles Tendon Defects in Rabbits. International Journal of Molecular Sciences, 26(14), 6800. https://doi.org/10.3390/ijms26146800

About InGeneron

InGeneron is a biotechnology company developing novel, safe, and evidence-based cell therapies. We are setting new therapeutic standards by enabling minimally invasive treatments that unlock the healing potential of each patient’s own regenerative cells processed at the point of care for same-day treatment. We currently focus on helping patients impacted by orthopedic conditions and are conducting several clinical trials to further validate our technology as a disease-modifying treatment. Backed by more than 20 years of research and a growing body of clinical evidence, we are committed to advancing safe, effective, and disease-modifying therapies that improve long-term patient outcomes.

InGeneron’s CE-marked Transpose Ultra^® System is commercially available in the EU. In the U.S., it is available for investigational use only and remains under clinical evaluation in several FDA-approved trials.

www.ingeneron.com