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

This study has been withdrawn prior to enrollment.
(Principal Investigator moved to Chile from Argentina)
Sponsor:
Information provided by:
University of Moron
ClinicalTrials.gov Identifier:
NCT00971503
First received: September 1, 2009
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Procedure: autologous bone marrow implantation
Other: Saline injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Método Para Regenerar el páncreas Con localización in Vivo de médula ósea Total Autologa en Pacientes diabéticos Tipo 1. Estudio Fase IIB.

Resource links provided by NLM:


Further study details as provided by University of Moron:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction by 50% of the insulin requirement after the transplant in 70% of the patients. [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Normalization of the hemoglobin A1C after transplant in 70% of the patients. Normalization of blood glucose levels. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: February 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971503

Locations
Chile
School of Medicine, Pontificia Universidad Catolica de Chile
Santiago de Chile, Chile
Sponsors and Collaborators
University of Moron
Investigators
Principal Investigator: Alejandro D. Mesples, MD University of Morón, School of Medicine
  More Information

No publications provided

Responsible Party: BMG Biotech
ClinicalTrials.gov Identifier: NCT00971503     History of Changes
Other Study ID Numbers: CM 02
Study First Received: September 1, 2009
Last Updated: July 26, 2011
Health Authority: Chile: Ministry of Health

Keywords provided by University of Moron:
Diabetes type 1
Adult Stem cells
Local injection
Catheter delivery
Bone marrow

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014