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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004349-29 | EudraCT Number |
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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.
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. Study participants from the MESRIX trial will be invited for a clinical visit. The visit will include medical history, an ENT examination; measurements of the saliva production by sialometry, a Magnetic resonance imaging scan (MRI) and obtaining data on the patient-reported outcome with Xerostomia Questionnaire (XQ) and Visual-Analogue-Symptomatic scale (VAS). Subjects, who are not able or willing to attend a clinical visit, will be encouraged to fill out the Questionnaires online or on paper. If a study participant has deceased, information of the cause of death will be investigated in The Danish Register of Causes of Death
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Adipose-derived mesenchymal stem cells | Experimental | Autologous adipose-derived mesenchymal stem cells transplanted intraglandular in patients with radiation-induced hyposalivation and xerostomia |
|
| Placebo | Placebo Comparator | 2 ml placebo: Isotonic NaCl (0.9mg(ml) and human albumin (HA) 1% |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous adipose-derived mesenchymal stem/stromal cells | Biological | Autologous adipose-derived mesenchymal stem/stromal cells |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Relapse of oropharyngeal cancer | Number of participants with relapse will be reported | 5 years from randomization |
| New malignancies | Number of subjects who have new malignancies will be reported | 5 years from randomization |
| Zoonotic Diseases | Number of subjects diagnosed Zoonotic Diseases will be reported | 5 years from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
1. Subjects who were not enrolled in the MESRIX trial
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Lynggaard, MD | Department of Otolaryngology, Rigshospitalet, Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otolaryngology, University Hospital of Copenhagen | Copenhagen | Denmark |
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Long-term follow-up of Randomized controlled trial MESRIX
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| Placebo | Other | Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1% |
|
| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D014987 | Xerostomia |
| D000069451 | Long Term Adverse Effects |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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