REFERENCES

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).

Islet Transplantation in the UK. CellR4. 2019;(7):e2788.

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.

France

France

Islet transplantation versus insulin therapy in patients with 

type 1 diabetes with severe hypoglycaemia or poorly 

controlled glycaemia after kidney transplantation 

(TRIMECO): a multicentre, randomised controlled trial

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

Why pancreatic islets should be regarded and regulated like organs?

G. C. Weir, S. Bonner-Weir 

 

2021

The pancreatic islet: a micro-organ in control.

Abdulreda MH, Berggren PO

FDA Regulations

CFR

Human Tissue Intended for Transplantation.

 

 21CFR Part 1270 

 

CFR

Human cells, tissues, and cellular and tissue-based products. (regulated under PHS Act Section 361)

 

21CFR Part 1271.10

 

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

Kessler D  

Regulation of somatic-cell therapy and gene therapy by the FDA

.

2002

Weber DJ,  

Selected Food And Drug Administration Review Issues For Regulation Of Allogeneic Islets Of Langerhans As Somatic Cell Therapy. Transplantation

.

2004

Weber DJ,  

Regulation of Allogeneic Islets as a Biological Product 

.

2018

Marks P.  

Balancing Safety and Innovation for Cell-Based Regenerative Medicine.

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