Funding call: Stem Cell Derived Beta Cell Product Validation Sites

Amount: Up to three grants available with the total for each site determined by the costs required by each Host Institution to deliver the work described.

Duration: ~12-months for the validation study with work likely commencing from the end of May 2025 subject to cell production and shipping arrangements.

Skills: Independent group leaders with teams who have a track record of working with and/or producing stem cell derived beta cells and studying them both in vitro and in vivo.

Location: Will fund up to three validation sites. The Principal Applicant at each location must be based at an academic Host Institution in the UK. Applications led by or including commercial organisations will be considered on a case by case basis.

Process: Short application submitted through the online grant’s portal, accompanied by a full financial breakdown, by 31 January 2025.

Purpose: To test and validate stem cell derived beta cell products manufactured by the Advanced Regenerative Manufacturing Institute (ARMI). Applicants may propose additional, related project tasks (e.g., the inclusion of additional stem cell derived beta cell sources for comparison).

There is a need to address the limited availability of stem cell derived beta cells for academic research studies. To achieve this at pace we have partnered with the Advanced Regenerative Manufacturing Institute (ARMI), based in New Hampshire, US. ARMI focuses on the scalable, consistent, cost-effective manufacture of cell-based products. Scaled manufacture will enable a reliable supply of stem cell derived beta cells to researchers, and the three original validation sites will be prioritised for consideration as major distribution hubs.

If you’re interested in applying, you can refer to some frequently asked questions here, or watch the below webinar recording and hear from Diabetes UK and ARMI teams, who have given more contexts to this funding call and some top tips for making a stand out application. Or you may refer to some frequently asked questions here.

Scope

The validation study is designed to determine cell viability in shipping from the US to the UK, as well as cell function both in vitro and in vivo. Flexibility on receipt and testing days will be needed due to the unknowns that can occur with international shipments. As above, applicants may propose additional, related project tasks (e.g., the inclusion of additional stem cell derived beta cell sources for comparison). To note, the three sites will need to use standard procedures to ensure the results are comparable and therefore, will be required to collaborate if successful. The same transplant procedure will also ideally be adopted at all three locations.

We are also open to applicants pitching to add a third comparator to the study, if they also have a proven protocol used in their laboratories to produce stem cell derived beta cells and test in vitro and in vivo. All results generated must be shared back with ARMI and each site will use aligned collection and reporting templates/platforms.

Scope of Work for the Stem Cell Derived Beta Cell Validation Study

The Scope of Work (SOW) includes the ability to:

Receive stem cell derived beta cells and maintain in culture until in vitro and in vivo assessment is performed;

Perform in vitro assays to assess stem cell derived beta cell morphologically, compositionally (e.g. by flow cytometry) and functionally (e.g. glucose-stimulated insulin secretion assay);

Perform 12-week in vivo assessment of the stem cell derived beta cells by implanting under the kidney capsule of a suitable mouse model of diabetes (e.g. streptozotocin-induction in an immunodeficient background) and assess by using the appropriate tests (e.g., blood glucose measurement, animal weight, human c-peptide, periodic intraperitoneal glucose tolerance test);

And perform histology on explanted grafts to assess graft durability.

Eligibility criteria

This call is open to non-clinical and clinical independent group leaders based at academic Host Institutions within the UK. Applications led by or including commercial organisations will be accepted and considered on a case by case basis, and we encourage you to contact the T1DGC Research Funding Team to discuss your application. Applications must be led by one Principal Applicant but can include other experts from their or other Host Institutions as Co-Applicants/Collaborators plus project management/co-ordinator support. As we will fund up to three sites that will be required to collaborate if successful, we are open to receiving applications that are interlinked from the start. But separate submissions will still be required.

Skills and expertise

In addition to experience of working with and/or producing and testing stem cell derived beta cells, the appropriate Home Office approvals should be in place, or able to be, by the earliest start date of 31 May 2025, to conduct the animal studies described.

Assessment criteria

Applications will be scientifically assessed by a subset of the Beta Cell Therapy Reviewer college, a group of international beta cell experts, and co-opted experts where necessary. The reviewers will focus on:

Relevant experience, skills, and expertise in beta cell therapy research.

The research environment and personnel, and the ability to conduct and deliver the experiments as described in the SOW provided as part of the funding call, within the timeframe described.

Ambition to help address this barrier to progress, the availability of stem cell derived beta cells for research purposes.

The recommendation from the Scientific Review Panel will be considered by ARMI, the Beta Cell Therapy Scientific Advisory Panel, who provide strategic guidance to the partnership, and the Type 1 Diabetes Grand Challenge Partnership Steering Group, composed of representatives from the three partner organisations Diabetes UK, the Steve Morgan Foundation and Breakthrough T1D UK.

Guidelines and Terms and Conditions

General Guidelines for Research Grant Applicants

Steve Morgan Foundation Type 1 Diabetes Grand Challenge Grant Conditions

A Material Transfer Agreement (MTA) will need to be signed for applicants to receive and test the cells. As this is a validation study using cells provided by ARMI some of the specific grant conditions for work funded by the Type 1 Diabetes Grand Challenge will not be relevant. For any work carried out on other cells sources, the standard terms apply.

Funding

Financial leverage is essential to the T1DGC initiative as we can do more together. Therefore, we ask that Applicants discuss this opportunity with their Host Institutions and explore how we can work in partnership, such as covering indirect costs and making contributions to the direct costs of research.

Funds can be used to cover:

Material and consumable costs.

Equipment costs will be considered on a case-by-case basis as the SOW has been designed to not require the use of specialist technology. Please contact the T1DGC Research Funding Team to discuss this further.

Project manager/co-ordinator costs are strongly encouraged but need to be fully justified within the application.

Staff salaries. For example: technicians, research assistants, postdoctoral researchers*. Applicants are encouraged to include named staff on proposals.

Travel and accommodation costs to visit collaborating institutes.

*Allowed/disallowed salary costs

Studentships are an ineligible cost for this funding call.

Diabetes UK will also not pay salaries on a cost recovery basis or for those already in receipt of a salary equivalent to 1FTE and is, therefore, unwilling to meet the salary costs of staff currently fully funded by the Higher Education Funding Council, NHS or equivalent. This usually applies to all Principal Applicants, Co-Applicants and Collaborators.

Where staff salaries are dependent on grant funding, we would require a letter from the Host Institute confirming they will not be in receipt of more than 1FTE for the duration of the award, if successful.

Diabetes UK will pay for named staff with specific expertise.

Costs for National Insurance contributions and any superannuation should be added to salary costs at the point of application. These costs will not be considered after an award has been made. Known salary increments may be included on the application form but national pay awards may not.
If you are unsure if the salary of a post will be covered, please contact the office to clarify.

To apply

You can submit your application via the online grant’s portal. We also encourage you to reach out to the T1DGC Research Funding Team to discuss the opportunity further before you apply.

About the Advanced Regenerative Manufacturing Institute (ARMI)

The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, New Hampshire, is a not-for-profit, Member-driven, public-private partnership found to bring the scalable, consistent, cost-effective manufacture of life-saving, cell-based technologies to scale. Bolstered by the expertise of nearly 200 industry, academic, and civic Members, ARMI is building a new industry: biofabrication, that will transform the future of healthcare and restore health and quality of life for patients, families, and communities around the globe.