NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTb070190057

Registered date:30/03/2020

Development of cell therapy for Salivary gland regeneration

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedxerostomia caused by radiation treatment
Date of first enrollment19/03/2019
Target sample size6
Countries of recruitmentJapan
Study typeOther
Intervention(s)Intervention: injection of E-MNC to the submandibular gland Intervention period: 1-year Number of times of intervention: 1 time

Outcome(s)

Primary OutcomeSafety
Secondary OutcomeEfficay (improvement of saliva secreation and gland volume)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria1. 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.
Exclude criteria1. 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.

Related Information

Contact

Public contact
Name Yoshinori Sumita
Address 1-7-1 Sakamoto Nagasaki Japan 852-8511
Telephone +81-95-819-7706
E-mail y-sumita@nagasaki-u.ac.jp
Affiliation Nagasaki University
Scientific contact
Name Izumi Asahina
Address 1-7-1 Sakamoto, Nagasaki Nagasaki Japan 851-8588
Telephone +81-95-819-7704
E-mail asahina@nagasaki-u.ac.jp
Affiliation Nagasaki University