Development of cell therapy for Salivary gland regeneration

JRCT ID: jRCTb070190057

Registered date:30/03/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: xerostomia caused by radiation treatment
• Date of first enrollment: 19/03/2019
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Other

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 Outcome: Safety
• Secondary Outcome: Efficay (improvement of saliva secreation and gland volume)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Asahina Izumi
• Source(s) of Monetary Support: CellAxia Inc.,Japan Agency for Medical Research and Development