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Creation of Bone Marrow Microenvironment for Treatment of MDS in Conjunction with Allogeneic Stem Cell Transplantation. - Article


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Bone Marrow Diseases




Clinical Trial: Creation of Bone Marrow Microenvironment for Treatment of MDS in Conjunction with Allogeneic Stem Cell Transplantation.

This study is currently recruiting patients.
Verified by Hadassah Medical Organization September 2005

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00148980

Purpose

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

We proved in experimental studies that the entire osteohematopoietic complex consisting of trabecular bone, hematopoietic microenvironment (of stromal origin) and hematopoietic tissue has been suffessfully 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 (MDS) by intraosseous inoculation of demineralized bone matrix (DBM) together with allogeneic bone marrow cells (BMC).

Condition Intervention Phase
Myelodysplastic syndrome (MDS)
Myelofibrosis
Allogeneic stem cell transplantation
Demineralized bone matrix (DBM)
Bone marrow microenvironment
 Device: DBM for creation of bone marrow microenvironment
Phase II

MedlinePlus related topics:  Bone Marrow Diseases

Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Further Study Details: 
Primary Outcomes: Enhancement of hematopoiesis in patients with myelofibrosis MDS by intraosseous demineralized bone matrix together with allogeneic bone marrow transplantation.
Expected Total Enrollment:  24

Study start: April 2003
Last follow-up: September 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00148980

Shimon Slavin, MD      +972-2-6776561    slavin@hadassah.org.il
Olga Gurevitch, PhD      +972-2-6778248    olga@hadassah.org.il

Israel
      Hadassah Medical Organization, Jerusalem,  91120,  Israel; Recruiting
Shimon Slavin, MD  +972-2-6776561    slavin@hadassah.org.il 

Study chairs or principal investigators

Olga Gurevitch, Ph.D,  Study Director,  Hadassah Medical Organization   

More Information

Study ID Numbers:  13-22-02-02
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00148980
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2005-09-13

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December 3, 2008



Page Updated: October 1, 2005
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