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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Withdrawn

Phase

Phase 2

Locations

Chile

Study Type

Interventional

Intervention

autologous bone marrow implantation

Saline injection

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Diabetes type 1, Adult Stem cells, Local injection, Catheter delivery, Bone marrow

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

School of Medicine, Pontificia Universidad Catolica de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

saline injection

Autologous bone marrow implantation

Arm Description

Outcomes

Primary Outcome Measures

Significant increase in C-peptide levels after transplant in 70% of the patient.

Secondary Outcome Measures

Reduction by 50% of the insulin requirement after the transplant in 70% of the patients.

Normalization of the hemoglobin A1C after transplant in 70% of the patients. Normalization of blood glucose levels.

Full Information

NCT ID

NCT00971503

First Posted

September 1, 2009

Last Updated

July 26, 2011

Sponsor

University of Moron

1. Study Identification

Unique Protocol Identification Number

NCT00971503

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Withdrawn

Why Stopped

Principal Investigator moved to Chile from Argentina

Study Start Date

February 2011 (undefined)

Primary Completion Date

February 2011 (Anticipated)

Study Completion Date

February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Moron

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

Diabetes type 1, Adult Stem cells, Local injection, Catheter delivery, Bone marrow

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

saline injection

Arm Type

Sham Comparator

Arm Title

Autologous bone marrow implantation

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

autologous bone marrow implantation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Saline injection

Intervention Description

Injection of saline solution for 5 days

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Reduction by 50% of the insulin requirement after the transplant in 70% of the patients.

Time Frame

Two years

Title

Normalization of the hemoglobin A1C after transplant in 70% of the patients. Normalization of blood glucose levels.

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alejandro D. Mesples, MD

Organizational Affiliation

University of Morón, School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Medicine, Pontificia Universidad Catolica de Chile

City

Santiago de Chile

Country

Chile

12. IPD Sharing Statement

Learn more about this trial

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

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