NCT02619734

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

9.9 years

First QC Date

November 30, 2015

Last Update Submit

December 1, 2015

Conditions

Chronic Leg UlcerSickle Cell Disease

Keywords

Cell TherapySickle cell diseaseAutologous implantationMesenchymal stromal cellEdothelial Progenitor cell

Outcome Measures

Primary Outcomes (2)

  • Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events

    Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events

    6 months

  • Change in Leg Ulcer

    Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded

    6 months to one year

Secondary Outcomes (3)

  • Numeric pain intensity scale (0-10)

    6 months to one year

  • Ulcer Healing

    6 months to one year

  • Quality of Life

    6 months to one year

Study Arms (2)

Control

NO INTERVENTION

Conventional treatment established by the good clinical practice Patients received standard local care dressing method (compresses) to heal leg ulcers

Stem Cell Injection

EXPERIMENTAL

Intramuscular implantation of Autologous bone marrow-derived mononuclear cells

Biological: Infusion of Autologous Bone Marrow Mononuclear Cells

Interventions

Infusion of Autologous Bone Marrow Mononuclear CellsBIOLOGICAL

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.

Stem Cell Injection

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Stable sickle cell disease patients
  • Patient hospitalized into the dermatology unit
  • Patient with an evolutive leg ulcer since more than 1 year
  • No infection at the time of surgery
  • Patient competent to give informed consent

You may not qualify if:

  • Patients with a history of corticosteroids or on active therapy
  • infection at the limb affected by ulcer
  • Recurrent painful crises,
  • Immunosuppressive drug therapy,
  • Pregnancy,
  • Presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of leg ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Daltro GC, Fortuna V, de Souza ES, Salles MM, Carreira AC, Meyer R, Freire SM, Borojevic R. Efficacy of autologous stem cell-based therapy for osteonecrosis of the femoral head in sickle cell disease: a five-year follow-up study. Stem Cell Res Ther. 2015 May 29;6(1):110. doi: 10.1186/s13287-015-0105-2.

    PMID: 26021713BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • José Valber Meneses, MD

    Federal University of Bahia

    STUDY CHAIR

  • Gildasio Daltro, MD

    Federal University of Bahia

    STUDY DIRECTOR

  • Vitor A Fortuna, PhD

    Federal University of Bahia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

August 1, 2006

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

December 2, 2015

Record last verified: 2015-11