Radiation Toxicity Clinical Trial
Official title:
Follow-up Study of Safety and Efficacy in Subjects Who Participated in the Study of Intraglandular Mesenchymal Stem Cells in Patients With Radiation-induced Hyposalivation and Xerostomia (MESRIX)
Verified date | October 2020 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial 2. Subjects who were treated with either autologous mesenchymal stem cells or placebo 3. Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial Exclusion Criteria: 1. Subjects who were not enrolled in the MESRIX trial |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Otolaryngology, University Hospital of Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: Serious Adverse Events (SAEs) and new chronic diseases | SAEs according to the ICH-GCP definition and new chronic diseases. For patients not attending the planned hospital visit consider searching The National Patient Register will be searched for registered SAEs. Number of patients | 5 years from randomization | |
Primary | Overall survival | Overall survival is defined as the time from the intraglandular dose of the investigational product (MSCs or placebo) to the date of death or the date the subject is last known to be alive | 5 years from randomization | |
Primary | Relapse of oropharyngeal cancer | Number of participants with relapse will be reported | 5 years from randomization | |
Primary | New malignancies | Number of subjects who have new malignancies will be reported | 5 years from randomization | |
Primary | Zoonotic Diseases | Number of subjects diagnosed Zoonotic Diseases will be reported | 5 years from randomization | |
Secondary | Patient-reported outcome measures-Health-related quality of life (HRQoL | Xerostomia Questionnaire (XQ) ( Median item scores for each of the 8 questions will be reported (score range 0-10) and the XQ summary/composite score (0-100)) | 5 years from randomization |
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