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Active, not recruitingNCT02872571AUTOGRAFTIMUpdated Apr 22, 2026

Evaluation of the Efficacy of Intramuscular Islet Autograft After Extensive Pancreatectomy

A Phase 1/2 interventional study of Intramuscular Islet Autograft in Disorder of Endocrine Pancreas, sponsored by University Hospital, Lille. Active, not recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by University Hospital, Lille · Phase 1/2, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 years 5 months after the study started (first participant enrolled Mar 2013, registered Aug 2016).
Phase
Phase 1/2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The liver may not be an optimal site for islet transplantation due to obstacles by an instant blood-mediated inflammatory response, and low revascularization of transplanted islets. Therefore, intramuscular islet transplantation offers an attractive alternative, based on its simplicity, enabling easier access for noninvasive graft imaging and cell explantation.

Read the detailed description

The field of β cell replacement therapies has progressed extensively over the last decades. It is well established that successful intraportal islet transplantation can restore endogenous β cell function to subjects with type 1 diabetes mellitus. In fact, when the graft function is optimal, insulin independence can be consistently prolonged for up to 5 years in 50% of patients. Several factors influence the outcome and performance of the graft upon implantation. For instance, preclinical studies have confirmed the significant differences in utilizing several sites for the implantation of islet grafts, but the most utilized clinical approach is embolization into the liver. However, it has become evidently clear that the liver may not be the optimal environment as a recipient site for pancreatic islets, owing not only to immunologic, but also to anatomic and physiologic factors that may promote a decline in islet function. Moreover, intrahepatic islet infusion is often associated with an immediate blood- mediated inflammatory reaction , thrombosis and hepatic tissue ischemia with elevated blood liver enzymes. In addition, the cross-talk between activated coagulation and inflammatory mediators after implantation, dramatically affects islet cell survival and engraftment, resulting in β cell dysfunction or death, depicting primary nonfunction as a consequence of reduced functional islet mass. This intrahepatic environment appears to potently impair the metabolic functions of transplanted islets. Furthermore, the complications associated with graft recovery within the hepatic site, will further limit its potential applications in exploiting insulin-secreting cells obtained from alternative cell sources. These include xenogenic islets, immortalized β cell lines, embryonic stem cells, or adult progenitor cells, including β cell encapsulation.

Restoration of β cell function is a highly desirable goal for patients with unstable diabetes; therefore, the search for an alternative site that is safer for islet transplantation is imperative.

In man, autotransplantation of minced tissue into striated muscle following blunt dissection has been successfully used in parathyroid surgery for several decades. Initially demonstrated in rodents in the early 1980s, intramuscular islet transplantation (IMIT) has rarely been considered as a clinically feasible implantation site.

This study want to provide direct evidence of the feasibility and function of autologous islets transplanted in the muscle

02

Conditions studied

  • Disorder of Endocrine Pancreas

Keywords

  • islet of Langerhans
  • transplantation
  • muscle
03

In context

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

age over 18 years indication for pancreatectomy for benign pancreatic disease not genetically determined (chronic pancreatitis, ductal lesions, neuroendocrine or cystic tumors) or pancreatic trauma

Exclusion criteria

Exclusion Criteria:

Patients with suspected lesion genetically determined or malignant on the basis of preoperative and / or during surgical exploration and / or during pathological examination Refusal to sign the consent form Patient not affiliated with a social security scheme Pregnant or lactating women Persons deprived of liberty, person under guardianship

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Intramuscular Islet Autograft

    Intramuscular Islet Autograft After Extensive Pancreatectomy

    Drug: Intramuscular Islet Autograft

Interventions

  • DrugIntramuscular Islet Autograft

    Intramuscular Islet Autograft After Extensive Pancreatectomy

06

What researchers measure

Primary outcomes

  1. the percentage of patients with a functioning graft in the arm 3 months after autograft.

    Graft function will be estimated by the difference in insulin response between the two arms after the test stimulus by arginine (Acute Insulin Response or AIRarg) .The graft will be considered functional (success) when the insulin response in the grafted arm will be at least 30% higher compared to the other arm, 3 months after transplantation.

    Time frame: 3 months

Secondary outcomes

  1. The percentage of patients with a functioning graft in the arm

    To demonstrate the function of transplanted islets in the arm in patients receiving autologous islet intramuscularly after undergoing pancreatectomy for benign lesion extent, to prevent post surgical diabetes.

    Time frame: 6 months, 12 months

  2. Continuous Glucose Monitoring System

    Continuous recording of blood glucose during 72 hours by Continuous Glucose Monitoring System

    Time frame: at baseline ( before autograft) at 3,6,12 months

  3. Oral Glucose Tolerance Test

    The glucose tolerance test is a medical test in which glucose is given and blood samples taken afterward to determine how quickly it is cleared from the blood.

    Time frame: at baseline ( before autograft) at 3,6,12 months

  4. hemoglobin A1c (HbA1c) blood test

    HbA1c measures blood glucose levels over a period of time.

    Time frame: at baseline ( before autograft) at 3,6,12 months

07

Study locations

4 sites
  • Chu Amiens Picardie
    Amiens, France
  • CHRU, Hôpital Claude Huriez
    Lille, France
  • Institut Paoli Calmettes
    Marseille, France
  • CHU Rouen
    Rouen, France
08

References and documents

Publications

  • Pattou F, Kerr-Conte J, Wild D. GLP-1-receptor scanning for imaging of human beta cells transplanted in muscle. N Engl J Med. 2010 Sep 23;363(13):1289-90. doi: 10.1056/NEJMc1004547. No abstract available. PubMed 20860517 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02872571
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Aug 19, 2016
Start date
Mar 2013
Primary completion
Apr 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Apr 22, 2026

Study contacts

François Pattou, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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