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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00148980

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes Myelofibrosis	Device: DBM for creation of bone marrow microenvironment	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.