Creation of Bone Marrow Microenvironment for Treatment of Myelodysplastic Syndrome (MDS) in Conjunction With Allogeneic Stem Cell Transplantation

April 27, 2011 updated by: Hadassah Medical Organization

Creation of Bone Marrow Microenvironment for Treatment of MDS in Conjunction With Allogeneic Stem Cell Transplantation

Normal bone marrow function depends on the coexistence of normal hematopoietic stem cells and a microenvironment mostly located in the medullary part of the bones. Stem cells cannot function properly in the absence of an adequate microenvironment. Whereas in malignant and non-malignant hematologic diseases caused by a deficiency or abnormal stem cells, stem cell transplantation is the treatment of choice that results in a cure, in diseases such as MDS, myelofibrosis, and other conditions associated with an abnormal microenvironment, pancytopenia may occur despite the presence of apparently normal hematopoietic cells with no recognizable cytogenetic abnormality.

We, the investigators at Hadassah Medical Organization, proved in experimental studies that the entire osteohematopoietic complex consisting of trabecular bone, hematopoietic microenvironment (of stromal origin) and hematopoietic tissue has been successfully transferred directly into ablated bone marrow cavity in a one-step transplantation procedure.

The goal of this study is to enhance hematopoiesis in patients with myelofibrosis syndrome by intraosseous inoculation of demineralized bone matrix (DBM) together with allogeneic bone marrow cells (BMC).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with impaired marrow stem cells by cytogenetic analysis or morphology (blasts), considered normal candidates for allogeneic BMT. Such patients will also be entitled to allogeneic bone marrow transplantation with intraosseous DBM.
  • Patients with documented myelofibrosis will be entitled to allogeneic bone marrow transplantation with intraosseous DBM.

Exclusion Criteria:

  • Patients with anticipated life expectancy of < 4 weeks.
  • Pregnant or lactating women.
  • Patients with an unrelated disease or relevant clinical problem that may not permit evaluation of the results of the study.
  • Patients under 18 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Enhancement of hematopoiesis in patients with myelofibrosis MDS by intraosseous demineralized bone matrix together with allogeneic bone marrow transplantation (BMT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Study Director: Olga Gurevitch, PhD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220202-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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