Product Positioning
MPB-2354 (RegenTrace™) is an allogeneic adipose-derived mesenchymal stem cell (ADSC) product developed by MegaPro Biomedical using its nanoparticle technology platform. A key feature is the incorporation of the Company’s proprietary iron oxide nanoparticles into ADSCs, enabling magnetic resonance imaging (MRI) to visualize the injection site and signal retention after cell implantation. Its immunomodulatory and angiogenesis-related effects have also been evaluated in preclinical studies.
Product Features
● Need for Cell Therapy Tracking
After cell therapy products are implanted in the human body, their distribution, retention, and signal changes are generally difficult to observe noninvasively. MPB-2354 combines the MRI contrast properties of iron oxide nanoparticles with allogeneic ADSCs. The development objective is to provide visual information for cell therapy research and support subsequent evaluation of the administration site, cell retention, dose, and route of administration.
● Product Type
Allogeneic ADSC cell therapy product labeled with iron oxide nanoparticles
● Primary Development Direction
No-option critical limb ischemia (No-option CLI), with MRI used to evaluate the implantation site and signal retention.
● Current Stage
Major preclinical development work and FDA Pre-IND consultation have been completed, and preparation for a Phase 1/2a IND is underway.
● Platform Potential
Potential expansion to other mesenchymal stem cells, T cells, and other cell therapy products.
Preclinical Research Features
● Cell Labeling: Iron oxide nanoparticles can be taken up by ADSCs, creating a cell product with an MRI signal.
● Cell Characteristics: Under the specified study conditions, no significant changes were observed in cell viability, phenotype, or trilineage differentiation capacity after nanoparticle labeling.
● Imaging Tracking: In animal studies, the MRI signal at the implantation site was observable for up to four weeks. The MRI signal indicates the presence of the iron oxide label and should not be directly interpreted as the number of viable cells or therapeutic efficacy.
● Functional Studies: In vitro studies showed increased VEGF- and IDO1-related expression, supporting further evaluation of angiogenic and immunomodulatory potential.
● Disease Model: In a mouse hindlimb ischemia model, the studies observed findings related to blood perfusion and limb preservation. These findings are preclinical and cannot predict efficacy in humans.
Primary Development Indication: No-option CLI
● MPB-2354 is currently being developed primarily for patients with critical limb ischemia who are not eligible for surgical or endovascular revascularization. Treatment options for these patients are limited. The Company plans to evaluate the safety, tolerability, feasibility of administration, and imaging-tracking information of MPB-2354 in an early-stage human trial.
R&D and Regulatory Progress
● A GMP process and product manufacturing capability have been established for allogeneic ADSCs labeled with iron oxide nanoparticles.
● Preclinical safety and efficacy studies supporting early-stage clinical development have been completed.
● A U.S. FDA Pre-IND consultation has been completed, and the Company is preparing a Phase 1/2a IND in accordance with regulatory feedback.
● In 2026, MPB-2354 won the Gold Award in the Healthcare category of the SelectUSA Tech Startup Competition.
Platform Expansion
● In addition to No-option CLI, MegaPro Biomedical continues to evaluate the combination of its nanoparticle-based cell-labeling technology with other mesenchymal stem cells, T cells, and various cell therapy products. These applications remain at the research or preclinical stage and will be advanced progressively based on technical validation, regulatory requirements, and collaboration opportunities.
Important Notice: MPB-2354 is an investigational product and has not received marketing authorization in any country or region. This content is provided solely to present the Company’s technology and R&D progress. It does not constitute product advertising, medical advice, or diagnostic or treatment recommendations. The product’s safety and efficacy remain subject to review and approval by the relevant regulatory authorities.