Reprocell Inc.

BELTSVILLE, Md., June 9, 2026 /PRNewswire/ -- REPROCELL (TYO: 4978) today announced that it has received a competitive Commercialization Award from the Maryland Stem Cell Research Fund (MSCRF). The funding will support the development of clinical grade, hypoimmune induced pluripotent stem cell (iPSC) seed stocks for clinical applications. The award is part of MSCRF's latest funding cycle dedicated to accelerating regenerative medicine technologies and stem cell-based therapies across Maryland.

The funded project aims to manufacture clinical grade hypoimmune iPSCs by combining REPROCELL's proprietary StemRNA™ reprogramming platform with StemEdit, a novel, AI-designed CRISPR-based gene editing technology. To ensure widespread availability of this universal cell technology, the new lines will be manufactured in REPROCELL's state-of-the-art U.S. cleanrooms, supported by the generation of a regulatory Drug Master File (DMF).

Additionally, the program will advance the development of a modular "landing pad" platform. This technology enables the precise insertion of therapeutic genes into genomic safe harbor loci within the iPSCs. REPROCELL anticipates that this plug-and-play approach will significantly simplify development workflows for future cell and gene therapies while vastly improving manufacturing scalability and consistency.

"Universal donor cell therapies represent one of the most critical frontiers for regenerative medicine, yet scalable manufacturing and immune compatibility remain major barriers for the field," said Rama Modali, CEO of REPROCELL USA Inc. "This award validates and supports our efforts to develop clinically relevant, hypoimmune iPSC platforms that seamlessly integrate AI-powered gene editing, GMP-compliant manufacturing, and modular engineering into a single workflow. We believe these technologies will accelerate timelines for therapeutic developers and expand patient access to next-generation cell therapies."

"MSCRF's mission is to advance stem cell and regenerative medicine research and innovation in Maryland through competitive, non-dilutive funding," said Ruchika Nijhara, Ph.D, executive director of MSCRF. "We are pleased to support projects that contribute to the growth of this important field and help strengthen Maryland's life sciences ecosystem." Demand for hypoimmune iPSC technologies continues to surge as the cell therapy industry shifts toward scalable, allogeneic ("off-the-shelf") approaches. By eliminating the need for patient-specific manufacturing and reducing dependence on long-term immunosuppression, REPROCELL's platform is uniquely positioned to address the critical bottlenecks facing modern medicine.

About REPROCELL

REPROCELL provides integrated stem cell, gene editing, and GMP manufacturing solutions supporting the entire path from discovery to clinical translation. With clinical grade iPSC generation (StemRNA™ Clinical iPSC), StemEdit gene editing, and GMP banking capability, REPROCELL serves academic, biotech, and pharmaceutical organizations seeking reliable, regulatory ready cell starting materials and services.

Website: www.REPROCELL.com 

About the Maryland Stem Cell Research Fund

Established under the Maryland Stem Cell Research Act of 2006 and overseen by the Maryland Stem Cell Research Commission, the Maryland Stem Cell Research Fund provides competitive, non-dilutive funding to advance stem cell and regenerative medicine research and innovation in Maryland. MSCRF supports academic and industry projects across the development continuum, from discovery through clinical translation, commercialization, and manufacturing.

Website: www.MSCRF.com

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SOURCE REPROCELL USA

Integrated Workflow Including Clinical Seed Production and StemEdit Gene Editing Services

BELTSVILLE, Md., March 3, 2026 /PRNewswire/ -- REPROCELL (TYO: 4978) today announced the launch of its US FDA compliant Good Manufacturing Practice (GMP) Master Cell Bank (MCB) manufacturing service for human induced pluripotent stem cells (iPSCs). Operating from its Beltsville, Maryland facility, REPROCELL now offers a comprehensive, end-to-end workflow for clinical iPSC manufacturing. This integrated service spans from StemRNA™ clinical seed iPSC manufacturing and StemEdit gene editing to GMP Master Cell Bank (MCB) production in compliance with FDA standards. By unifying these critical steps, REPROCELL enables cell therapy developers to accelerate IND submissions while reducing regulatory and manufacturing uncertainty.

As part of this platform, the StemRNA Clinical iPSC Seed Clone – LLF-34-F3, derived from US sourced donor material, is supported by an active FDA Drug Master File (DMF). This clone has been expanded into a GMP MCB using FDA-compliant closed system processes. This off-the-shelf GMP iPSC MCB is now available for commercial use, providing ready-to-use clinically validated starting material. For sponsors requiring European alignment, REPROCELL also offers MCB/WCB manufacturing through its partner, Histocell. This service operates with a GMP certificate and authorization from the Spanish Agency for Medicines and Medical Devices (AEMPS) under European Medicines Agency (EMA) oversight.

Key Highlights: Clinical iPSC Capabilities

• Donor sourcing and eligibility meet FDA, EMA, and PMDA requirements with full consent for therapeutic use.
• Footprint-free proprietary RNA reprogramming to generate StemRNA™ Clinical iPSC Seed Clones under FDA/EMA/PMDA requirements.
• US-generated StemRNA Clinical Seed Clones supported by an active FDA DMF
• Genetic integrity and oncogenic risk assessment using whole-genome sequencing (WGS) for StemRNA Clinical Seed Clones
• StemEdit clinical gene editing service, engineered for high on target efficiency with reduced off target activity and lower predicted immunogenicity
• GMP MCB manufacturing in compliance with FDA or under EMA and PMDA authorization to manufacture

About StemRNA™ Clinical iPSC Seed Clone – LLF-34-F3

StemRNA™ Clinical iPSC Seed Clone – LLF-34-F3 is derived from a healthy O+ female US donor, fully consented for commercial and therapeutic use, and is homozygous at HLA-A and HLA-DPA1 loci enhancing its potential for allogeneic applications. The seed clone meets FDA, EMA and PMDA standards and is supported by a DMF while GMP MCB expansion uses FDA-compliant processes providing a traceable clinically ready starting material.

REPROCELL also offers options of StemRNA™ Clinical iPSC Seed Clones from different donor profiles.

Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc., commented:

"By completing clinical iPSC workflow starting from donor screening, seed iPSC manufacturing, StemEdit gene editing, and GMP cell banking under one coordinated framework, we are delighted to provide cell therapy developers a streamlined path for clinical program development. This integrated platform is designed to accelerate IND/CTA submissions while preserving quality, traceability, and global regulatory alignment."

About REPROCELL

REPROCELL provides integrated stem cell, gene editing, and GMP manufacturing solutions supporting the entire path from discovery to clinical translation. With clinical grade iPSC generation (StemRNA™ Clinical iPSC), StemEdit gene editing, and GMP banking capability, REPROCELL serves academic, biotech, and pharmaceutical organizations seeking reliable, regulatory ready cell starting materials and services.

This work was supported by a Commercialization Grant (no. 2024-MSCRFCO-6418) from the Maryland Stem Cell Research Fund (MSCRF)

For more information, visit www.reprocell.com. 

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SOURCE REPROCELL USA