Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus

NCT00315614 | Terminated Phase 2 Results DMC

• 2 other identifiers: 2000/0024R01DK056953
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

SPECIFIC AIMS:

• To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes mellitus by islet cell transplantation.
• To induce a state of donor specific tolerance and eliminate the need for continuous immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells with islets and utilization of the monoclonal antibody Campath-1H for induction of Immunosuppression.
• To assess long-term function of successful islet cell transplants in patients with Type 1 diabetes mellitus.
• To determine whether the natural history of the microvascular, macrovascular and neuropathic complications are altered following successful transplantation of islet

Conditions

Type 1 Diabetes Mellitus

Keywords

Islet Transplantation

Outcome Measures

Primary Outcomes (2)

• The Achievement of Persistent Islet Function Following Cessation of Immunosuppression.

  Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.

  for the duration of islet graft function

• A Reduction or Absence of Rejection Episodes

  Number of rejection episodes after transplantation. Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.

  for the duration of islet graft function

Secondary Outcomes (2)

• Number of Subjects With Basal C-peptide Greater Than 0.5 ng/ml

  for the duration of islet graft function

• Number of Subjects With Reduction of Severe Hypoglycemia and Improvement in Hypoglycemia Awareness

  for the duration of islet graft function

Study Arms (1)

Islet Transplantation and Bone Marrow

EXPERIMENTAL

Administration of islets and infusion of CD34 enriched Bone Marrow cells in subjects with type 1 diabetes, impaired awareness of hypoglycemia and severe hypoglycemia.

Biological: Islet Transplantation and Bone Marrow

Interventions

Islet Transplantation and Bone Marrow BIOLOGICAL

Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes.

Also known as: Islet, type 1 DM, Bone marrow

Islet Transplantation and Bone Marrow

Eligibility Criteria

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

You may qualify if:

• Patients between 18 and 65 years of age
• Patients with type 1 diabetes mellitus for more than 5 years duration
• One or more of the following:
• Hypoglycemia unawareness - judged by history of blood sugars \<54 on glucometer without symptoms and/or hypoglycemic episodes requiring assistance from either family, glucagon administration or emergency services
• Poor diabetes control (HbA1c\>8% or \>2 visits/yr to hospital for treatment of ketoacidosis) despite intensive insulin therapy
• Progressive complications of type 1 diabetes mellitus
• Body Mass Index (BMI) ≤26

You may not qualify if:

• Untreated proliferative diabetic retinopathy;
• HbA1C \> 12%;
• Insulin requirement \> 1.0u/kg/d
• Stimulated or basal C-peptide \> 0.3 ng/ml
• Creatinine clearance \< 60 and/or serum creatinine consistently \> 1.5mg/dl;
• Macroalbuminuria \> 300mg albumin in 24 hours
• Presence of panel reactive antibodies \> 20%;
• Previous/concurrent organ transplantation (except failed islet cell transplantation);
• Any medical condition requiring chronic use of steroids;
• Malignancy or previous malignancy (except non-melanomatous skin cancer);
• X-ray evidence of pulmonary infection;
• Active infections;
• Positive tuberculin test (unless proof of adequate treatment for latent tuberculosis can be provided)
• Active peptic ulcer disease,
• Gall stones and/or portal hypertension and/or hemangioma on liver ultrasound;

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Diabetes Research Institute Foundation: collaborator

Study Sites (1)

Diabetes Research Institute

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Tharavanij T, Betancourt A, Messinger S, Cure P, Leitao CB, Baidal DA, Froud T, Ricordi C, Alejandro R. Improved long-term health-related quality of life after islet transplantation. Transplantation. 2008 Nov 15;86(9):1161-7. doi: 10.1097/TP.0b013e31818a7f45.

  PMID: 19005394 DERIVED

Related Links

• Diabetes Research Institute web site

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Islets of Langerhans Transplantation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Rodolfo Alejandro
• Organization: University of Miami

ralejand@med.miami.edu

3052435324

Study Officials

• Rodolfo Alejandro, MD

  Diabetes Research Institute University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 14, 2006
• First Posted: April 18, 2006
• Study Start: December 1, 2000
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 4, 2017
• Results First Posted: February 10, 2014

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)