Trials / Unknown
UnknownNCT03876197
Mesenchymal Stem Cells for Radiation-induced Xerostomia
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)
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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. 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
Conditions
- Radiation Toxicity
- Xerostomia Due to Radiotherapy
- Dry Mouth
- Hyposalivation
- Mesenchymal Stem Cells
- Mesenchymal Stromal Cells
- Long Term Adverse Effects
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Autologous adipose-derived mesenchymal stem/stromal cells | Autologous adipose-derived mesenchymal stem/stromal cells |
| OTHER | Placebo | Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1% |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2022-12-01
- Completion
- 2023-12-01
- First posted
- 2019-03-15
- Last updated
- 2020-10-22
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03876197. Inclusion in this directory is not an endorsement.