Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells

NCT00023491 | Completed

• 2 other identifiers: 01023401-D-0234
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graft vs Host Disease; Sjogren's Syndrome

Keywords

Sjogren's Syndrome; Peripheral Blood Stem Cell; Tissue Regeneration; Graft-versus-host Disease; Head and Neck Cancer; Salivary Gland; Saliva Gland; Salivary Gland Dysfunction

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• We will review medical records of patients enrolled in NHLBI protocol who are 18 years of age or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1089/10763270050044380.

  PMID: 10941215 BACKGROUND

• 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. doi: 10.1111/j.1749-6632.1999.tb08512.x.

  PMID: 10415576 BACKGROUND

• Baum BJ. Principles of saliva secretion. Ann N Y Acad Sci. 1993 Sep 20;694:17-23. doi: 10.1111/j.1749-6632.1993.tb18338.x. No abstract available.

  PMID: 8105741 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease; Sjogren's Syndrome; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Immune System Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 7, 2001
• First Posted: September 7, 2001
• Study Start: September 1, 2001
• Study Completion: October 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-10

Locations

US (1)