Bone Marrow Autotransplantation in Type 1 Diabetes

NCT ID: NCT00821899

Last Updated: 2012-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

Brief Summary

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This project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow blood will be obtained by multifunction in the posterior iliac crest. The material obtained will be implanted into the pancreas through the magna pancreatic artery after femoral catheterization.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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administration of autologous bone marrow blood

administration of autologous bone marrow blood through magna pancreatic artery after femoral catheterization once during 12-month study period

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* diabetes type 1 patients
* 18 to 50 years of age
* more than 5 years of evolution of the disease
* brittle diabetes (HbA1c \> 8.5 % with intensified treatment or severe hypoglycemia episodes

Exclusion Criteria

* history of cancer
* hematologic alterations
* infectious disease positivity (HIV, HCV etc.)
* diabetic nephropathy
* cardiac failure
* liver disease
* autoimmune systemic disease
* allergy to iodine contrast or anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Enric Esmatjes

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esmatjes Enric, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Enric Esmatjes

Barcelona, Barcelona, Spain

Site Status

Hospital Clinic

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Esmatjes E, Montana X, Real MI, Blanco J, Conget I, Casamitjana R, Rovira M, Gomis R, Marin P. Regeneration of insulin production by autologous bone marrow blood autotransplantation in patients with type 1 diabetes. Diabetologia. 2010 Apr;53(4):786-9. doi: 10.1007/s00125-010-1660-9. Epub 2010 Jan 26. No abstract available.

Reference Type DERIVED
PMID: 20101385 (View on PubMed)

Other Identifiers

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BMATxDM1

Identifier Type: -

Identifier Source: org_study_id

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