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Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease

NCT02619734 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-12-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease.

Conditions

Interventions

BIOLOGICAL

Infusion of Autologous Bone Marrow Mononuclear Cells

Autologous bone marrow-derived mononuclear cells will be administered by intramuscular injection into and around the leg ulcer. The number of injected cells will be from 5x108 to 1x109 total number of cells on Study Day 1.

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • Federal University of Bahia

    lead OTHER

Principal Investigators

  • José Valber Meneses, MD · Federal University of Bahia

  • Gildasio Daltro, MD · Federal University of Bahia

  • Vitor A Fortuna, PhD · Federal University of Bahia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2016-07-31
Completion
2016-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02619734 on ClinicalTrials.gov