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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00148980
Other study ID # 220202-HMO-CTIL
Secondary ID
Status Withdrawn
Phase Phase 2
First received September 7, 2005
Last updated April 27, 2011
Start date April 2003

Study information

Verified date February 2006
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 24
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
DBM for creation of bone marrow microenvironment


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Enhancement of hematopoiesis in patients with myelofibrosis MDS by intraosseous demineralized bone matrix together with allogeneic bone marrow transplantation (BMT)
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