Graft vs Host Disease Clinical Trial
Official title:
Assessment of the Potential of Hematopoietic Stem Cells to Transdifferentiate Into Salivary Gland and Oral Mucosal Epithelial Cells in Adult Bone Marrow Transplant Patients
This study will examine whether transplanted stem cells can turn into salivary gland cells
in stem cell recipients. If so, stem cells might be used to restore salivary gland function
in patients with Sjogren's syndrome and other causes of dry mouth. People with severe dry
mouth may develop difficulty swallowing, severe tooth decay, infections of the mouth and
pharynx, and mouth sores.
Female patients 18 years of age and older who are enrolled in the National Heart, Lung and
Blood Institute's protocol 97-H-009 or 97-H-0202 and who have received a stem cell
transplant from a male donor may be eligible for this study. Five patients with graft-versus
host disease (GVHD) and five without GVHD will be included. GVHD is a transplantation
reaction in which the donor's cells mount an immune response against the recipient's
tissues. Patients with chronic GVHD have mouth ulcerations and dry mouth similar to that of
patients with Sjogren's syndrome. Five healthy female volunteers will also be enrolled.
Participants will have a medical and dental history. Then, cells will be collected from the
inside of the cheek (buccal cell scraping) and from the salivary glands (labial gland
biopsy) as described below:
Buccal cell scraping - Cells are collected from the inside of the cheek by wiping for 5
seconds with a plastic brush.
Labial glands biopsy - The lower lip will be numbed and a small incision will be made on the
inside of the lower lip. Six small salivary glands in the lower lip will be removed and the
incision will be closed with four stitches.
Cells collected from these procedures will be examined to see if donated stem cells turned
into salivary gland or cheek cells.
Patients will return to the clinic 5 to 10 days after the biopsy to have the stitches
removed and assess healing.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: We will review medical records of patients enrolled in NHLBI protocol who are 18 years of age or older. EXCLUSION CRITERIA: This study excludes any subjects younger than 18 years old. Female subjects recruited for this study would ideally have no prior history of male childbearing or abortion. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Dental And Craniofacial Research (NIDCR) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Aframian DJ, Cukierman E, Nikolovski J, Mooney DJ, Yamada KM, Baum BJ. The growth and morphological behavior of salivary epithelial cells on matrix protein-coated biodegradable substrata. Tissue Eng. 2000 Jun;6(3):209-16. — View Citation
Baum BJ, Wang S, Cukierman E, Delporte C, Kagami H, Marmary Y, Fox PC, Mooney DJ, Yamada KM. Re-engineering the functions of a terminally differentiated epithelial cell in vivo. Ann N Y Acad Sci. 1999 Jun 18;875:294-300. Review. — View Citation
Baum BJ. Principles of saliva secretion. Ann N Y Acad Sci. 1993 Sep 20;694:17-23. Review. — View Citation
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