Frequently Asked Questions (FAQ)
Regenerative Medical Solutions is developing an iPSC-based functional cure for diabetes, a therapy designed to restore the body’s natural ability to produce insulin, without donor organs, immunosuppressive drugs, or an implantable device. Along the way, we get a lot of questions.
This resource covers the science behind our work, the global diabetes challenge we’re working to solve, our therapy in development, and how researchers and partners can work with us. Select any question to read the full answer, or browse by topic below.
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What is Regenerative Medical Solutions?
Regenerative Medical Solutions (RMS) is a privately held biotechnology company based in Madison, Wisconsin, developing a functional cure for diabetes using induced pluripotent stem cell (iPSC) technology. Founded in 2012, RMS is advancing a regenerative medicine platform designed to restore the body's natural ability to produce insulin, with the goal of eliminating patients' lifelong dependence on insulin injections.
Where is Regenerative Medical Solutions based?
Regenerative Medical Solutions is headquartered at 505 S Rosa Road, Suite 26, Madison, Wisconsin 53719. The company operates within one of the Midwest's most active life sciences communities, a region home to leading research universities, established biotechnology companies, and a strong network of academic and industry collaborators.
Who founded Regenerative Medical Solutions?
Regenerative Medical Solutions was co-founded by Dr. Jon Odorico, MD, FACS, a pancreatic transplant surgeon and stem cell scientist with more than 20 years of research experience in islet biology and diabetes. Dr. Odorico began his career at the University of Wisconsin Hospital in 1995, where he witnessed firsthand the limitations of donor organ transplantation as a treatment for diabetes; limitations that drove his commitment to finding a stem cell-based alternative.
What stage of development is RMS's diabetes therapy at?
RMS's iPSC-derived Islet-Like Cluster (ILC) cellular therapeutic is currently in preclinical development. The therapy candidates are being evaluated in laboratory studies and animal models, assessing both efficacy (the ability to restore insulin production and regulate blood glucose) and safety, prior to human administration.
What funding and validation does RMS have?
RMS's research program is supported by grant funding from the National Institutes of Health (NIH), a significant marker of scientific validation for a company at the preclinical stage. NIH funding is awarded on the basis of rigorous peer review and represents external recognition of the scientific merit and potential impact of RMS's work.
What is RMS's mission?
The mission of Regenerative Medical Solutions is to develop an affordable, scalable, and ethically grounded prospective functional cure for diabetes through regenerative medicine. RMS aims to translate decades of academic stem cell research into a real-world therapeutic that restores natural insulin production in patients with Type 1 and Type 2 diabetes, without the need for donor organs, chronic immunosuppressive drugs, or implantable devices.
Understanding Diabetes & Current Treatments
What is the difference between managing diabetes and curing it?
The difference between managing diabetes and curing it is fundamental to understanding why stem cell research matters. Current diabetes treatments, primarily insulin therapy for type 1, and a range of medications and lifestyle interventions for type 2, are highly effective at controlling blood glucose levels and reducing the risk of complications. They are, in many cases, lifesaving. But they do not address the underlying cause of the disease.
Why can't islet transplantation be scaled to treat all diabetes patients?
Islet transplantation is one of the closest existing approaches to a functional cure for diabetes. The procedure involves transplanting insulin-producing islet cells from a donor pancreas into a patient, where they can restore natural insulin production and, in successful cases, eliminate the need for insulin injections. When it works, it offers a genuine glimpse of what a diabetes cure could look like.
What are the biggest unmet needs in diabetes treatment today?
Despite decades of progress in diabetes care, significant unmet needs remain. The most fundamental is the absence of a widely accessible cure. Existing treatments require continuous daily management and do not restore the body's natural insulin-producing function. For the approximately 589 million adults living with diabetes globally, this means a lifelong commitment to medication, monitoring, and the management of complications.
What is the difference between Type 1 and Type 2 diabetes?
Type 1 and Type 2 diabetes are distinct conditions that share a common outcome (the inability to regulate blood glucose effectively) but arise through different biological mechanisms. Understanding the difference between them is important for appreciating the breadth of RMS's research program.
Stem Cell Therapy & iPSC Technology
What is stem cell therapy for diabetes?
Stem cell therapy for diabetes is an approach to treating the condition that uses stem cells (unspecialized cells capable of developing into many different cell types) to restore the insulinproducing function that diabetes destroys. Rather than managing blood glucose externally through insulin injections, stem cell therapy aims to regenerate or replace the pancreatic beta cells responsible for natural insulin production.
What is an iPSC platform?
An iPSC platform is the integrated set of technologies, protocols, and manufacturing processes used to reliably generate, expand, and differentiate induced pluripotent stem cells into specific target cell types. Building a robust iPSC platform is one of the central technical challenges in translating stem cell science into clinical and commercial reality; it requires not just the ability to produce the right cells, but to do so consistently, at scale, and to a quality standard suitable for therapeutic use.
What is stem cell differentiation?
Stem cell differentiation is the process by which an unspecialized stem cell develops into a specific cell type with a defined biological function. All cells in the human body, from neurons to heart muscle cells to insulin-producing beta cells, originate from stem cells that have undergone differentiation. In a developing embryo, this process is orchestrated by complex biological signals. In the laboratory, scientists can replicate and direct this process by exposing stem cells to carefully controlled sequences of growth factors and chemical signals
What is regenerative cellular therapy?
Regenerative cellular therapy is a category of medical treatment that uses living cells (typically derived from stem cells) to repair or replace cells, tissues, or organs that have been lost or damaged by disease, injury, or ageing. It is a subcategory of regenerative medicine, distinguished by its focus on delivering therapeutic benefit through the transplantation or engraftment of functional cells rather than through drugs or devices.
How are stem cells used in regenerative medicine?
Stem cells are used in regenerative medicine in three broad ways: as research tools for studying disease, as platforms for drug discovery and testing, and as direct therapeutic agents in cellular therapies designed to restore lost or damaged biological function.
RMS's Diabetes Cure in Development
How is RMS developing a cure for diabetes?
RMS is developing a prospective functional cure for diabetes using induced pluripotent stem cell (iPSC) technology. The approach begins with the reprogramming of adult cells, either from the patient themselves or from a donor cell line, into iPSCs. These iPSCs are then directed, through RMS's proprietary differentiation protocols, to develop into Islet-Like Clusters (ILCs): cellular structures that closely replicate the composition and function of natural human pancreatic islets, including insulin-producing beta cells, glucagon-producing alpha cells, and somatostatinproducing delta cells.
What is autologous versus allogeneic cell therapy?
Autologous and allogeneic refer to two fundamentally different approaches to the source of cells used in a cellular therapy, and the distinction has significant implications for immune compatibility, manufacturing, and patient accessibility.
What is an Investigational New Drug (IND) application?
An Investigational New Drug (IND) application is a formal submission made to the United States Food and Drug Administration (FDA) that requests permission to begin clinical trials of a new therapeutic in human participants. It is a critical regulatory milestone in the development of any new drug or biologic, including cell-based therapies like RMS's iPSC-derived ILC therapeutic.
What is the clinical trial process for a new diabetes therapy?
The clinical trial process for a new diabetes therapy, or any new biologic or cell-based treatment, follows a structured regulatory pathway designed to evaluate safety and efficacy progressively before a therapy is made widely available to patients.
What makes RMS's stem cell therapy for diabetes different from others in development?
Several iPSC-based diabetes therapies are currently in development globally, but RMS's approach is distinguished by a combination of features that set it apart from the majority of competing programs.
ILC Cells, Products & Research Tools
What are Islet-Like Clusters (ILCs)?
Islet-Like Clusters (ILCs) are iPSC-derived cellular structures designed to closely mimic the insulin-producing islets of the human pancreas. RMS's proprietary ILCs are generated to closely replicate the composition and function of natural human pancreatic islets. They are derived from induced pluripotent stem cells using RMS's proprietary differentiation protocols, and contain insulin-producing beta-like cells, glucagon-producing alpha cells, and somatostatin-producing delta cells, reflecting the multi-cellular composition of native pancreatic islets
What is the RMS ILC Cell Kit used for?
The RMS ILC Cell Kit is a research product containing iPSC-derived Islet-Like Clusters, supplied as cryopreserved single cells ready for use in laboratory applications. It is intended for researchers and pharmaceutical companies working in diabetes research, drug development, and toxicity screening who require a reliable, scalable, and human-relevant source of pancreatic cells.
What is ProgenMix™ and how is it used?
ProgenMix™ is RMS's proprietary pancreatic differentiation media formulation, designed to support the efficient and reproducible generation of PDX1+ pancreatic progenitor cells and endocrine cell types from induced pluripotent stem cells. It is intended for researchers and biotech companies that wish to generate pancreatic cells in-house, rather than purchasing ready-to-use cells through the ILC Cell Kit.
Ethics & Safety
Does RMS use embryonic stem cells in its research?
No. Regenerative Medical Solutions does not use embryonic stem cells in any part of its research or product development. This is a deliberate and fundamental aspect of RMS's scientific and ethical approach.
Why does RMS's therapy not require immunosuppressive drugs?
The need for lifelong immunosuppressive therapy is one of the most significant limitations of existing cell transplantation approaches for diabetes, including cadaveric islet transplantation. These drugs work by broadly suppressing the immune system to prevent it from rejecting Regenerative Medical Solutions - FAQ Master Document Page 15 transplanted cells, but in doing so, they significantly increase patients' long-term vulnerability to infections, certain cancers, and other serious health consequences. They represent a substantial and ongoing clinical burden that limits the suitability of many cell therapies for widespread patient use.
Is RMS's stem cell therapy suitable for all blood types?
Yes. RMS's iPSC-based stem cell therapy is being designed to work across all blood types, an important practical consideration for any therapy intended to reach a broad patient population.
Does RMS's therapy require an implantable device?
No. RMS's iPSC-based therapy does not require the use of an implantable device, another feature that distinguishes it from some other cell therapy approaches currently in development for diabetes.
What are the ethical considerations in stem cell research for diabetes?
Stem cell research for diabetes raises a number of ethical considerations that vary depending on the type of stem cells used and the methods employed. Understanding these considerations is important for researchers, funders, and partners evaluating stem cell programs.
Collaborating & Partnering with RMS
What collaboration opportunities does RMS offer?
RMS is open to a range of collaboration models reflecting the different ways that pharmaceutical companies, biotech organizations, and academic institutions might engage with the company's platform and expertise.
What biotech consulting services does RMS offer?
RMS offers personalized biotech consulting services drawing on its deep scientific expertise in regenerative medicine, iPSC biology, and translational research. These services are designed for biotechnology companies, pharmaceutical organizations, and research institutions that want access to specialist knowledge in stem cell development and therapy translation, either to support their own internal programs or to evaluate new scientific opportunities.
How is RMS different from other biotech consulting firms?
What distinguishes RMS from other biotech consulting firms is the direct scientific experience that underpins its consulting practice. RMS is not primarily a consulting firm, it is an active biotech company in the process of developing and advancing its own iPSC-based therapeutic program. Its consulting insights are grounded in the reality of doing the work: building a stem cell platform, developing proprietary differentiation protocols, managing an intellectual property portfolio, navigating preclinical development, and preparing for clinical translation.
Can RMS help evaluate a new stem cell therapy concept?
Yes. RMS offers early-stage scientific feasibility assessments and strategic input for biotech companies, research teams, and product developers looking to evaluate the biology and commercial potential behind a new stem cell therapy concept or iPSC-based platform.
Does RMS work with academic institutions and government agencies?
Yes. RMS has deep and longstanding roots in academic research, and collaboration with universities, public research institutions, and government agencies is a natural extension of the company's scientific heritage. RMS was itself founded on academic research conducted at the University of Wisconsin–Madison, and Dr. Jon Odorico's laboratory has a long history of productive collaboration with other leading stem cell and diabetes researchers, including Dr. James Thomson, who pioneered the isolation of human embryonic stem cells.
How can I get in touch with RMS about a partnership or collaboration?
Organizations and individuals interested in partnering with Regenerative Medical Solutions, whether for research collaboration, co-development, licensing, consulting, or broader strategic engagement, are welcome to get in touch directly with the RMS team.