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Bone Marrow Diseases |
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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
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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
Expected Total Enrollment: 24
Study start: April 2003
Last follow-up: September 2005
Eligibility
Inclusion Criteria:
- Patients with impaired marrow stem cells by cytogenetic analysis or morphology (blasts), considered normal candidates for allogeneic BMT. Such patients will be also entitled for allogneic bone marrow transplantation with intraosseous DBM.
- Patients with documented myelofibrosis will be entitled for 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.
Location and Contact Information
Olga Gurevitch, PhD +972-2-6778248 olga@hadassah.org.il
Israel
Hadassah Medical Organization, Jerusalem, 91120, Israel; Recruiting
Olga Gurevitch, Ph.D, Study Director, Hadassah Medical Organization
More Information
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
Resources
- American Cancer Society
- Amyloidosis (MayoClinic)

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