Protocol to Obtain Bone Marrow for Research

Bone Marrow Biopsy Clinical Trial

Official title:

Protocol to Obtain Bone Marrow for Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951925
• Other study ID #: D0529
• Status: Completed
• Start date: June 2005
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Potential donors who are undergoing bone marrow biopsy or bone marrow donation as part of clinical care will be asked by the principal investigator (PI) if they might be interested in donating marrow for this research project. If they are interested, the PI will meet with the prospective donor to review the information contained in the informed consent document and to answer any questions the potential subject may have. Bone marrow aspirates of approximately 5cc will be obtained from the posterior iliac crest of subjects using standard techniques.

Description:

The purpose of this study is to determine the mechanisms that regulate human globin gene expression by analyzing the function of cell signaling pathways and the expression of other related genes and their protein products in the bone marrow cells of people without blood diseases. This includes the effects of drugs and other in vitro manipulations of the cells once they are removed from donors. These assays will include, but are not limited to, determinations of DNA methylation status, histone acetylation profiles, DNAse sensitivity, transcription factor binding to DNA, levels of various proteins, messenger RNAs and miRNAs in the cells of the marrow samples. By understanding how this process occurs in people without blood diseases, we hope to to design future treatments for people with diseases such as sickle cell disease and B-thalassemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing diagnostic bone marrow biopsies at the Norris Cotton Cancer Center of DHMC.

• Patients undergoing bone marrow harvesting for autologous bone marrow transplantation.

• Normal donors undergoing bone marrow harvesting for autologous bone marrow transplantation.

• Normal persons over the age of 17 who volunteer to undergo bone marrow aspiration.

Exclusion Criteria:

• Normal volunteers with known allergies to lidocaine (or similar analgesics)or betadine.

Related Conditions & MeSH terms

• Bone Marrow Biopsy

Intervention

Other:
• Bone Marrow Aspirate Draw
5cc of Bone Marrow Aspirate will be drawn

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regulation of human globin gene expression	The purpose of this study is to determine the mechanisms that regulate human globin gene expression by analyzing the function of cell signaling pathways and the expression of other related genes and their protein products in the bone marrow cells of people without blood diseases.	Ongoing