The "Islets for US" Collaborative

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Our collaborative is composed of over 50 experts and leaders in the field of islet and pancreas transplantation deeply concern about over 20-year lack of  the access to life saving islet transplantation for Americans with type 1 diabetes, severe hypoglycemic episodes and hypoglycemia unawareness. 

 

Therefore:

1. We have prepared a comprehensive report, which included a root-cause analysis of the existing problem.

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2. We have identified major deficiencies in the current regulatory approach to the islets in the US, which lead to  the imminent demise of the entire field of islet transplantation, or alternatively to unsafe and detrimental for the field and patients, commercialization of the human pancreas and islets for clinical transplantation. 

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3. Based on our analysis, we identified critical elements of the necessary regulatory update, which we propose to the FDA and HHS for considerations.

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4. Instead of deficient islet regulation as drugs, we propose islet regulation under the existing regulatory framework for organ transplantation in the US ,under the UNOS and OPTN, along with components of the FDA regulations for human cell and tissue for transplantation exempt from the drug regulations. Proposed regulatory updated can be easy implemented by the decision of the Secretary of the HHS, as it was done previously for vascularized composite tissue.

 

5. Unfortunately, despite evidence and rationale we provided,  regulators do not see the need for the regulatory update. 

We wrote  several letters to the FDA, HHS, HRSA, CMS, UNOS and published 6 articles in peer -reviewed scientific journals voicing our concerns and providing arguments for the regulatory update.

We presented our position during the FDA Experts Advisory Committee Meeting in April 2021 and during the Scientific Sessions of the  American Diabetes AssociationCongress in June 20021. (see below)

 

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Key negative consequences of the deficiencies in the current islet regulations

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Imminent demise of islet transplantation in the US

Over last 10 years, we have witnessed a decline of  islet transplantation in the US, as the procedure remained limited only to experimental settings due to outdated islet regulations, Regulations of human islets as drugs preclude safe transition of the islet transplantation to the standard of care procedure available to diabetic patients in the US. Lack of the financial support system and reimbursment precludes any islet transplantation activity.

 

Reference:

The demise of islet allotransplantation in the United States: A call for an urgent regulatory update. Am J Transplant, 2021, 21:1365–1375.

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Deficiency of drug manufacturing procedures and regulations in the reassurance of islet quality and sterility. 

Recent scientific evidence and FDA's own report clearly indicate that the current regulation of human islets as drugs does not reassure safety and effectiveness of the therapy as intended to. Islet sterility and quality prior to transplant cannot be reassured despite the application of the drug manufacturing procedures and regulations during islet preparation for the transplantation. 

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Reference:

Pancreatic Islets Quality and Potency Cannot be Verified as Required for Drugs. Transplantation 2021, Jul 1, 

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Imminent threat of the commercialization of human pancreas and islets for clinical transplantation without proper reassurance of islet quality and patient safety

Despite above,  the FDA still considers granting a Biological License to a single for-profit company  to market human islets for transplantation in the US, which would further compromise patient safety, lead to unsafe and detrimental commercialization of human pancreas and islets for clinical transplantation in the US .  

 

The continuation the islet regulation as drugs has multiple negative consequences for the future of islet and organ transplantation and diabetes care for the US public.

 

Reference:

1. Regulatory updates are needed to prevent the commercialization of islet transplantation in the United States. Am J Transplant (2021) 21:2620–2622.

2. Islet transplantation in the United States – Quo Vadis? An interview with Camilo Ricordi (CR), Ali Naji (AN), Peter Stock (PS), Piotr Witkowski (PW). Transpl Int (2021) 34:1177–1181.  

3. Arguments against the Requirement of a Biological License Application for Human Pancreatic Islets: The Position Statement of the Islets for US Collaborative Presented during the FDA Advisory Committee Meeting. J Clin Med (2021) 10:2878.

4. Islet Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress" Frontiers in Endocrinology, 2022 in press.