Safety and Efficacy of Arterial Delivery of Autologous Bone Marrow Cells in the Treatment of Insulin-Dependent Diabetes

NCT ID: NCT00971503

Last Updated: 2011-07-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-02-29

Brief Summary

Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Exogenous administration of insulin is the primary method of controlling type 1 diabetes by regulating blood glucose levels, but this treatment does not reverse nor prevent disease progression.

Our hypothesis is that when implanting stimulated total bone marrow by arterial injection directly into the pancreas, we will achieve functional recovery of insulin-producing cells. This study will include patients with chronic type 1 diabetes and absence of lesions in target organs. We will follow the evolution of patients receiving autologous total bone marrow implantation by selective catheterization and compare to a non-treatment control group. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control.

The objective is to achieve a significant increase in C-peptide levels indicating a regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least 70% of the patients.

This study is a follow-up to our initial study in which 22 patients received autologous total bone marrow. The initial study was 100% safe but additional studies like the one described above are needed to show efficacy.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

saline injection

Group Type: SHAM_COMPARATOR

Saline injection

Intervention Type: OTHER

Injection of saline solution for 5 days

Autologous bone marrow implantation

Group Type: EXPERIMENTAL

autologous bone marrow implantation

Intervention Type: PROCEDURE

Filgrastim treatment before bone marrow aspiration that will then be implanted via pancreatic artery

Interventions

autologous bone marrow implantation

Filgrastim treatment before bone marrow aspiration that will then be implanted via pancreatic artery

Intervention Type: PROCEDURE

Saline injection

Injection of saline solution for 5 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between 18-30 years of age, diagnosed with diabetes mellitus Type 1 (insulin-dependent).
• Negative antibody titers for GAD and anti-islet.
• Measurements of serum C-peptide below normal values.
• BMI 20-25, men, 19-24, women

Exclusion Criteria

• Diabetes type 2, gestational diabetes, and other types of secondary diabetes.
• Patients with acute metabolic complications of diabetes such as ketoacidosis at least within the last 6 months.
• Abdominal perimeter >102 cm in men; >88cm in women
• Fasting glycemia >100 mg/dl, triglycerides >150 mg/dl, HDL < 40 mg/dl.
• Blood pressure: SBP >135 mmHg and DBP >85 mmHg at the time of randomization
• Patients with BMI > 25 for men and >24 for women.
• Patients weighing < 40 kg.
• Patients with abnormal ECG indicative of acute or chronic ischemia or acute/chronic necrosis.
• Patients with anemias of any origin.
• Patients undergoing antibiotic treatment for acute infection.
• Patients with any blood abnormality.
• Patients with history of moderate to severe pancreatitis.
• A female subject who is breast-feeding, pregnant, intends to become pregnant or refuses to use a contraceptive method during the course of the study.
• Patients allergic to iodine or filgrastim.
• Patients using medications that could affect this study.
• Patients with serious mental conditions.
• Patients who have undergone a previous stem cell treatment.
• Patients who do not accept and sign the informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Moron

OTHER

Sponsor Role: lead

Principal Investigators

Alejandro D. Mesples, MD

Role: PRINCIPAL_INVESTIGATOR

University of Morón, School of Medicine

Locations

School of Medicine, Pontificia Universidad Catolica de Chile

Santiago, Santiago de Chile, Chile

Countries

Chile

Other Identifiers

CM 02

Identifier Type: -

Identifier Source: org_study_id