Islets for US
Collaborative
2021 Jun
Pancreatic islet quality and potency cannot be verified as required for drugs: Reflection on the FDA review of the Biological Islet Application for Human Islets.
Just accepted for the publication in Transplantation!
2021 Jun
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
Just accepted for publication in the Journal of Clinical Medicine!
2021 May
Islet Transplantation in the US - Quo Vadis?
An Interview with Camilo Ricordi (CR), Ali Naji (AN), Peter Stock (PS), Piotr Witkowski (PW)
Transplant International
2021 Feb
Regulatory updates are needed to prevent the
commercialization of islet transplantation in the United States
American Journal of Transplantation
2020
REPORT. Islet Transplantation in the US.
"Islets for US" Collaborative
American Journal of Transplantation
2019
C. Ricordi, A. Japour
Transplanting islet cells can fix brittle diabetes. Why isn’t it available in the U.S.?
STAT NEWS (Boston Globe Media), CellR4 2019; 7: e2768
Current status of islet transplantation in countries outside the US
United Kingdom
Johnson PRV
On behalf of the UK Islet Transplant Consortium (UKITC).
Canada
Australia
O’Connell PJ. Kay TWH.
On behalf of the Australian Islet Transplant Consortium.
Establishing a national program of islet transplantation in Australia. CellR4. 2019;(7):e2797.
Poland
Dębska-Ślizień A, Wszoła M, Bachul P, et al.
Islet Transplantation – perspective from Poland. CellR4. 2019;7:e2786.
Italy
France
France
Islet transplantation versus insulin therapy in patients with
type 1 diabetes with severe hypoglycaemia or poorly
controlled glycaemia after kidney transplantation
Islet Transplantation results from
the Collaborative Islet Transplantation Registry
2015
10th Annual CITR Report
2014
Islet product characteristics and factors related to successful human islet transplantation from the Collaborative Islet Transplant Registry (CITR) 1999-2010.
.
2012
Improvement in outcomes of clinical islet transplantation: 1999-2010.
.
2012
Islet Transplantation in Type 1 Diabetes: Ongoing Challenges, Refined Procedures, and Long-Term Outcome.
.
Regulations related to human islet for clinical transplantation
USA
Regulatory considerations for human cells, tissue and cellular and tissue-based products: minimal manipulation and homologous use. Guidance for industry and FDA staff. 2020.
EU vs US
Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States
.… human islets for the treatment of severe forms of type 1 diabetes is a common example of cell/tissue products that might be regarded as non-ATMPs, since these cells/ tissues might be isolated, purified, and cultured by methods that do not result in a modification of the biological characteristics and are re-administered to fulfill their same essential function...
2012
Potent induction immunotherapy promotes long-term insulin independence after islettransplantation in type 1 diabetes.
.
EU
Reflection paper on classification of advanced therapy medicinal products. 2015
EMA/CAT/600280/2010 rev.1
Committee for Advanced Therapies (CAT)
NOTA and HHS amendments regarding definition of human organs
2007
Inclusion of blood vessels for organ transplantation into the definition of organ and exclusion from HCT/P
Islets are micro-organs
2021
2021
FDA Regulations
CFR
CFR
Human cells, tissues, and cellular and tissue-based products. (regulated under PHS Act Section 361)
cGTP
FDA Guidance for Industry
Current Good Tissue Practice (cGTP)
....We are not recommending clean room classification requirements for particular facilities or manufacturing steps. You should determine the appropriate level of control. The appropriate level of control may depend on such factors as which manufacturing steps are involved, whether they are performed in an open or closed system, whether they are performed in a laminar flow hood (LFH) or biological safety cabinet (BSC), and other factors as described in the FDA guidance entitled “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice” dated September 2004 (Ref. 6). This guidance could provide useful information to an HCT/P establishment that is developing procedures on environmental control and monitoring...
FDA Publications
1993
2002
Weber DJ,
Selected Food And Drug Administration Review Issues For Regulation Of Allogeneic Islets Of Langerhans As Somatic Cell Therapy. Transplantation
.