Development of cell therapy for Salivary gland regeneratio

Phase 1

• Conditions: xerostomia caused by radiation treatment

• Registration Number: JPRN-jRCTb070190057
• Lead Sponsor: Asahina Izumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-30
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Patients who are suffering form sever xerostomia caused by the radiotherapy for head and neck cancer.
2. Patients who have no recurrence of head and neck cancer more than 5 years after treatment.
3. Patients who complain the xerostomia and whose saliva flow rate is in the range of less than 10ml/10min.
4. Patients who are detected the salivary gland atrophy by CT examination.

Exclusion Criteria

1. Hemoglobin concentration in peripheral blood
1) blood collection within 200ml
male: less than 12.5g/dl of hemoglobin concentration
femal: less than 12.0g/dl of hemoglobin concentration
2) blood collection with 200ml and over (within 240ml)
male: less than 13.0g/dl of hemoglobin concentration
femal: less than 12.5g/dl of hemoglobin concentration
2. Patients who had got salivary gland tumor as a primary disease.
3. Patients who have any cancer and sepsis.
4. Patients who suffer from severe endocrine metabolic disease and autoimmune disease.
5. Patients who are posiitive of sphilis, HBV-antigen, HCV-antigen, HTLV-1-antibody and HIV-antibody.
6. Patients who are judged as improper to join in this study by the principal investigator or co-investigators.

Study & Design

• Study Type: Other
• Study Design: Not specified