Status:
UNKNOWN
Mesenchymal Stem Cells for Radiation-induced Xerostomia
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Radiation Toxicity
Xerostomia Due to Radiotherapy
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX.
Detailed Description
This is a LTFU study to assess the long-term and late effects of treatment with MSCs or placebo given ultrasound-guided into the submandibular glands in subjects participating in the MESRIX trial. Stu...
Eligibility Criteria
Inclusion
- Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial
- Subjects who were treated with either autologous mesenchymal stem cells or placebo
- Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial
Exclusion
- 1\. Subjects who were not enrolled in the MESRIX trial
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03876197
Start Date
August 1 2020
End Date
December 1 2023
Last Update
October 22 2020
Active Locations (1)
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1
Department of Otolaryngology, University Hospital of Copenhagen
Copenhagen, Denmark