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

July 26, 2011 updated by: University of Moron

Método Para Regenerar el páncreas Con localización in Vivo de médula ósea Total Autologa en Pacientes diabéticos Tipo 1. Estudio Fase IIB.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago de Chile, Chile
        • School of Medicine, Pontificia Universidad Catolica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: saline injection
Other: Saline injection
Injection of saline solution for 5 days
Experimental: Autologous bone marrow implantation
Procedure: autologous bone marrow implantation
Filgrastim treatment before bone marrow aspiration that will then be implanted via pancreatic artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant increase in C-peptide levels after transplant in 70% of the patient.
Time Frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
1 month, 3 months, 6 months, 12 months, 18 months, 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction by 50% of the insulin requirement after the transplant in 70% of the patients.
Time Frame: Two years
Two years
Normalization of the hemoglobin A1C after transplant in 70% of the patients. Normalization of blood glucose levels.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Moron

Investigators

  • Principal Investigator: Alejandro D. Mesples, MD, University of Morón, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

July 27, 2011

Last Update Submitted That Met QC Criteria

July 26, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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