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Clinical Trials/JPRN-jRCTb070190057
JPRN-jRCTb070190057
Active, not recruiting
Phase 1

Phase 1 Clinical Study of Cell Therapy with Effective-Mononuclear Cells (E-MNC) for Radiogenic Xerostomia (First-in-human Study) - FIH study on E-MNC therapy for radiogenic xerostomia

Asahina Izumi0 sites6 target enrollmentMarch 30, 2020
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Asahina Izumi
Enrollment
6
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 30, 2020
End Date
TBD
Last Updated
last year
Study Type
Other
Sex
All

Investigators

Sponsor
Asahina Izumi

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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