Novel Method of Pancreatic Islet Transplantation Into the Omentum

NCT04884633 | Unknown

• 1 other identifier: 17-29009A
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to conduct a pilot clinical study in 10 type 1 diabetic subjects suffering from hypoglycemia unawareness syndrome and episodes of severe hypoglycemia, in which therapy with transplantation of allogeneic pancreatic islets would be indicated according to current criteria at the Institute for Clinical and Experimental Medicine (IKEM). Pancreatic islets will be isolated and prepared for transplantation using the established laboratory technique with minor modifications corresponding to latest knowledge. In contrast to present routine, the islet preparation will not be administered percutaneously into the portal vein but will be placed on the surface of an omental pouch using a (mini) laparoscopic approach. Cell adherence will be achieved by addition of clinical-grade human thrombin that reacts with plasma to create a biocompatible, degradable gel containing the islet graft. The study will be performed in close collaboration with the Diabetes Research Institute (DRI) in Miami, which will provide expert assistance and technical training if needed.

Conditions

Islets of Langerhans Transplantation

Keywords

Pancreatic islets; Transplantation; Diabetes; Omentum

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  The rate of serious adverse events

  1 year

• Achieving good metabolic control of diabetes

  achieving glycosylated HbA1c 53 mmol/mol at 1 year post-transplant and no severe hypoglycemia events from day 28 to 365 inclusive after the islet transplant.

  1 year

Secondary Outcomes (5)

• Insulin requirement

  6 and 12 months

• C-peptide

  6 and 12 months

• Quality of life assessed by the Short Form 36 questionnaire score

  12 months

• Infections

  1 year

• The rate of significat glomerula filtration rate reduction

  6 months and 1 year

Interventions

Pancreatic islet transplantation PROCEDURE

New method of pancreatic islet transplantation into the omentum using a biodegradable scaffold

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 to 65 years, ability to comply with the procedures of the study protocol.
• Clinical history of type 1 diabetes with onset at \< 40 years of age, insulin-dependence for \> 5 years at the time of enrollment.
• Absent stimulated C-peptide (\<0,3 ng/l) in response to mixed meal test measured at 60 and 90 minutes after the start of consumption.
• Involvement in intensive diabetes management, defined as self-monitoring of glucose values no less that mean of three times each day averaged over each week and by the administration of three or more insulin injections each day or in-sulin pump. Management under the direction of a diabetologist with at least 3 clin¬ical evaluations during the12 months prior to study enrollment.
• At least on episode of severe hypoglycemia in the 12 months prior to the study enrollment
• Reduced awareness of hypo glycaemia (as specified in detail in the full protocol) during the screening period OR marked glycemic lability characterized by wide swings in blood glucose despite optimal diabetes therapy

You may not qualify if:

• Body Mass Index (BMI) \>30 kg/m2 or patient weight ≤50 kg.
• Insulin requirement of \>1.0 IU/kg/day or \<15 U/day.
• glomerular filtration rate \<80 mL/min/1.73 m2

Sponsors & Collaborators

• Frantisek Saudek: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine, Department of Diabetes

Prague, 14021, Czechia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Islets of Langerhans Transplantation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Endocrine Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Frantisek Saudek

  Institute for Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frantisek Saudek

CONTACT

603804597; frsa@medicon.cz

Lenka Nemétová

CONTACT

neml@ikem.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD., prof.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 13, 2021
• Study Start: August 15, 2019
• Primary Completion: December 31, 2022
• Study Completion: August 31, 2023
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)