Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells
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|ClinicalTrials.gov Identifier: NCT00023491|
Recruitment Status : Completed
First Posted : September 7, 2001
Last Update Posted : March 4, 2008
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.
|Condition or disease|
|Graft vs Host Disease Sjogren's Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|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|
|Study Start Date :||September 2001|
|Estimated Study Completion Date :||October 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023491
|United States, Maryland|
|National Institute of Dental And Craniofacial Research (NIDCR)|
|Bethesda, Maryland, United States, 20892|