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NCT00023491 · ClinicalTrials.gov registry record
Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells
A clinical trial, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- 10
- Enrollment target
NCT00023491: Completed study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT00023491 is a clinical trial that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00023491 has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2001-09 |
| Est. Completion | 2004-10 |
What the finished NCT00023491 record still lists
NCT00023491 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00023491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00023491 about?
NCT00023491 is a clinical study titled "Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells". 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 difficult...
What is the current status of trial NCT00023491?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2001-09. Estimated completion is 2004-10.
Who is sponsoring clinical trial NCT00023491?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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