Islets for US
Collaborative
Landmark multi-center trials proving
safety and effectiveness of islet transplantation
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
US
Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes
Complicated by Severe Hypoglycemia (CIT-07)
US
Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes
Current status of islet transplantation in countries outside the US
World
Berney T.
A Worldwide Survey of Activities and Practices in Clinical Islet of
Langerhans Transplantation
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
Regulations related to human islet for clinical transplantation
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...
NOTA and HHS amendments regarding definition of human organs
1984
Islets are micro-organs
2021
The pancreatic islet: a micro-organ in control.
Abdulreda MH, Berggren PO
2021
The Human Islet: Mini-Organ With Mega-Impact.
Powells AC et al.
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
.
2004
2018