Safety and Efficacy of Arterial Delivery of Autologous Bo... | NCT00971503

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

NCT00971503

Sponsor

University of Moron

Status

Withdrawn

Last Update Posted

Jul 27, 2011Estimated

Enrollment

34Estimated

Phase

Phase 2

Conditions

Type 1 Diabetes Mellitus

Interventions

autologous bone marrow implantation
Saline injection

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator moved to Chile from Argentina

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Feb 2011Estimated

Completion Date

Feb 2012Estimated

First Submitted Date

Sep 1, 2009

First Submission Date that Met QC Criteria

Sep 2, 2009

First Posted Date

Sep 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2011

Last Update Posted Date

Jul 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
saline injection	Sham Comparator		Other: Saline injection
Autologous bone marrow implantation	Experimental		Procedure: autologous bone marrow implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
autologous bone marrow implantation	Procedure	Filgrastim treatment before bone marrow aspiration that will then be implanted via pancreatic artery	Autologous bone marrow implantation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals