Investigator-initiated clinical trials of Effective-Mononuclear Cell (E-MNC/CA-702) therapy for irreversible radiogenic injury to salivary glands.

JRCT ID: jRCT2073240123

Registered date:06/03/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Xerostomia Due To Radiation-Induced Salivary Gland Dysfunction
• Date of first enrollment: 06/03/2025
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Administration of CA-702

Outcome(s)

Primary Outcome

1) Adverse eventsand malfunctions
2) Laboratory test value fluctuations
3) Oral examination

Secondary Outcome

1) Changes in stimulated salivary secretion in the Saxon test from baseline
2) Changes in subjective symptoms of xerostomia from the previous observation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

1) Patients with head and neck cancer who have undergone radiotherapy , with a period of at least 2 years elapsed since the last treatment date, showing no recurrence, and with salivary gland atrophy confirmed by CT or MRI.
2) Subjects with subjective symptoms of orbital dryness
3) Individuals with Saxon test results within a specific range.
4) Patients who show ineffectiveness or intolerance to oral dryness symptom-improving drugs (muscarinic receptor agonists).
5) Non-smokers. If the patient has a history of smoking, he/she may be included if he/she has been smoke-free for at least 9 months.

Exclude criteria

1) Persons who have difficulty performing the Saxon test (e.g., elderly persons with chewing difficulties)
2) Patients with suspected xerostomia due to causes other than radiation-induced salivary gland atrophy disorder
3) Patients with a history of administration of high-functioning cell E-MNC
4) Patients whose primary disease was salivary gland tumor
5) Patients who have participated or are participating in a clinical trial of an unapproved drug, regenerative medicine product, or medical device within 6 months of the start of preanalytical observation, or who are planning to participate in another clinical trial during this study.

Related Information

• Primary Sponsor: Sumita Yoshinori