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Long-term Follow-up Study of Mesenchymal Stem Cells for Radiation-induced Xerostomia (MESRIX)

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ClinicalTrials.gov Identifier: NCT03876197
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Charlotte Lynggaard, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Radiation Toxicity Xerostomia Due to Radiotherapy Dry Mouth Hyposalivation Mesenchymal Stem Cells Mesenchymal Stromal Cells Long Term Adverse Effects Biological: Autologous adipose-derived mesenchymal stem/stromal cells or placebo Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Long-term follow-up of Randomized controlled trial MESRIX
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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) Phase 1/2 Trial
Estimated Study Start Date : March 25, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Experimental: Autologous Adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells transplanted intraglandular in patients with radiation-induced hyposalivation and xerostomia
Biological: Autologous adipose-derived mesenchymal stem/stromal cells or placebo
Intraglandular injections of Autologous adipose-derived mesenchymal stem/stromal cells or placebo

Placebo Comparator: Placebo
2 ml placebo: Isotonic NaCl (0.9mg(ml) and human albumin (HA) 1%
Biological: Autologous adipose-derived mesenchymal stem/stromal cells or placebo
Intraglandular injections of Autologous adipose-derived mesenchymal stem/stromal cells or placebo




Primary Outcome Measures :
  1. Safety: Serious Adverse Events (SAEs) and new chronic diseases [ Time Frame: 5 years from randomization ]
    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

  2. Overall survival [ Time Frame: 5 years from randomization ]
    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

  3. Relapse of oropharyngeal cancer [ Time Frame: 5 years from randomization ]
    Number of participants with relapse will be reported

  4. New malignancies [ Time Frame: 5 years from randomization ]
    Number of subjects who have new malignancies will be reported

  5. Zoonotic Diseases [ Time Frame: 5 years from randomization ]
    Number of subjects diagnosed Zoonotic Diseases will be reported


Secondary Outcome Measures :
  1. Patient-reported outcome measures-Health-related quality of life (HRQoL [ Time Frame: 5 years from randomization ]
    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))

  2. Saliva gland function [ Time Frame: 5 years from randomization ]
    Mean difference of unstimulated saliva productions between groups adjusted for baseline unstimulated saliva production Sialometry, unstimulated Whole saliva flow rate (ml/min)

  3. Composition of saliva [ Time Frame: 5 years from randomization ]
    Mean difference of composition of saliva between groups adjusted for baseline unstimulated saliva production

  4. Size of Submandibular glands [ Time Frame: 5 years from randomization ]
    4. Mean difference of size of the submandibular glands between groups adjusted for baseline size of the submandibular glands



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876197


Contacts
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Contact: Charlotte Lynggaard, MD +45 6124 2795 clyn0015@regionh.dk
Contact: Christian Buchwald, Professor +4535452370 christian.von.buchwald@regionh.dk

Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Charlotte Lynggaard, MD Department of Otolaryngology, Rigshospitalet, Copenhagen, Denmark

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Responsible Party: Charlotte Lynggaard, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03876197     History of Changes
Other Study ID Numbers: CVB2019-1
2014-004349-29 ( EudraCT Number )
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Charlotte Lynggaard, Rigshospitalet, Denmark:
Xerostomia Due to Radiotherapy

Additional relevant MeSH terms:
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Xerostomia
Long Term Adverse Effects
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Pathologic Processes