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Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation


Phase 4
18 Years
60 Years
Open (Enrolling)
Both
Hematological Malignancies

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Trial Information

Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation


Inclusion Criteria:



- Hematological malignancies

- Indication of allogenic transplantation

- No suitable donor (related/unrelated)

- No suitable cord blood unit with enough cellularity for standard transplant

- Written informed consent

Exclusion Criteria:

- ECOG > 2

- Co-morbidities

- HIV positive serology

- Pregnancy or breastfeeding

- Psychiatric illness

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Kinetics of hematopoietic engraftment

Outcome Time Frame:

days 14, 21, 28 after administration

Safety Issue:

No

Principal Investigator

Montserrat Rovira, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Clinic Barcelona

Authority:

Spain: Ethics Committee

Study ID:

TPH/SCU-IMed 01/08

NCT ID:

NCT00838019

Start Date:

February 2009

Completion Date:

February 2011

Related Keywords:

  • Hematological Malignancies
  • Neoplasms
  • Hematologic Neoplasms

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