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Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy

Primary Purpose

Xerostomia Due to Radiotherapy

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
mesenchymal cells
Sponsored by
Institut de Terapia Regenerativa Tissular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia Due to Radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients from 18 to 75 years old of both sexes.
  2. Biochemical analysis without significant alterations which could contraindicate the treatment.
  3. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
  4. 2 years of follow-up without recurrence.
  5. Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min.
  6. Grade 1-3 xerostomy as assessed by the grading scale.
  7. The patient is able to understand the nature of the study.
  8. Written informed consent of the patient

Exclusion Criteria:

  1. Participation in another clinical trial in the 3 months prior to his/her inclusion.
  2. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
  3. Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
  4. History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
  5. Xerogenic medication in progress.
  6. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
  7. Local infection.
  8. Pregnancy or pregnancy planned within the next 2 years.
  9. Breastfeeding.
  10. Treatment with anticoagulants (not interruptible in MO or application).
  11. Any other illness or condition that is grounds for exclusion for the investigator.

Sites / Locations

  • Institut de Terapia Regenerativa Tissular

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment with mesenchymal stem cells

Arm Description

xerostomy using mesenchymal stem cells adult autologous bone marrow

Outcomes

Primary Outcome Measures

Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire
Absolute and relative change of the score of the OHIP Questionnaire (OHIP-14-sp)
Changes in the characteristics and degree of discomfort of xerostomia.
Absolute and relative change of the score of the EVA Questionnaire
Sialometry results
Absolute and relative change in the volume of saliva (ml / min) submaxillary
Restoration of the glandular structure.
Changes in the glandular structure (volume) (MRI with contrast)
Restoration of the glandular structure.
Changes in the glandular structure (vascularization) (MRI with contrast)
Restoration of the glandular structure.
Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)
Measurement of submaxillary gland functionalism changes based on Gammagraphy
Measurement of submaxillary gland functionalism changes based on Gammagraphy

Secondary Outcome Measures

AEs and SAEs
Determination of the Safety of the proposed procedure, recording adverse events (AEs) and serious adverse events (SAEs). It will be considered as early safety measures: Pain at the site of injection, submaxillary swelling, duration of submaxillary swelling in days, oral discomfort, infection

Full Information

First Posted
November 5, 2018
Last Updated
November 14, 2018
Sponsor
Institut de Terapia Regenerativa Tissular
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1. Study Identification

Unique Protocol Identification Number
NCT03743155
Brief Title
Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy
Official Title
Phase II Clinical Trial to Evaluate the Effect and Safety of MSV * in Xerostomia * Adult Autologous Bone Marrow Mesenchymal Stem Cells, Expanded Under GMP of IBGM
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2018 (Anticipated)
Primary Completion Date
May 30, 2019 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Terapia Regenerativa Tissular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase II not controlled, open-label, prospective, single center clinical trial
Detailed Description
Determine changes in the xerostomia characteristics and discomfort degree by means of questionnaires addressed to the physician and subject of study. Determine the volume of submaxilar saliva without stimulation and with stimulation by sialometry (SL). Detect changes in volume, vascularization and fibrosis of submaxillary glands based on magnetic resonance imaging (MRI) with contrast. Detect changes of submaxillary gland functionalism based on Gammagraphy (GF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia Due to Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
single arm due to not alternative treatment exist
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment with mesenchymal stem cells
Arm Type
Experimental
Arm Description
xerostomy using mesenchymal stem cells adult autologous bone marrow
Intervention Type
Biological
Intervention Name(s)
mesenchymal cells
Intervention Description
Autologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out. The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration
Primary Outcome Measure Information:
Title
Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire
Description
Absolute and relative change of the score of the OHIP Questionnaire (OHIP-14-sp)
Time Frame
24 months
Title
Changes in the characteristics and degree of discomfort of xerostomia.
Description
Absolute and relative change of the score of the EVA Questionnaire
Time Frame
24 months
Title
Sialometry results
Description
Absolute and relative change in the volume of saliva (ml / min) submaxillary
Time Frame
24 months
Title
Restoration of the glandular structure.
Description
Changes in the glandular structure (volume) (MRI with contrast)
Time Frame
24 months
Title
Restoration of the glandular structure.
Description
Changes in the glandular structure (vascularization) (MRI with contrast)
Time Frame
24 months
Title
Restoration of the glandular structure.
Description
Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)
Time Frame
24 months
Title
Measurement of submaxillary gland functionalism changes based on Gammagraphy
Description
Measurement of submaxillary gland functionalism changes based on Gammagraphy
Time Frame
24 months
Secondary Outcome Measure Information:
Title
AEs and SAEs
Description
Determination of the Safety of the proposed procedure, recording adverse events (AEs) and serious adverse events (SAEs). It will be considered as early safety measures: Pain at the site of injection, submaxillary swelling, duration of submaxillary swelling in days, oral discomfort, infection
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients from 18 to 75 years old of both sexes. Biochemical analysis without significant alterations which could contraindicate the treatment. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a. 2 years of follow-up without recurrence. Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min. Grade 1-3 xerostomy as assessed by the grading scale. The patient is able to understand the nature of the study. Written informed consent of the patient Exclusion Criteria: Participation in another clinical trial in the 3 months prior to his/her inclusion. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion). Patients with positive serologies for HIV, lues and hepatitis with positive viral load. History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa. Xerogenic medication in progress. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc. Local infection. Pregnancy or pregnancy planned within the next 2 years. Breastfeeding. Treatment with anticoagulants (not interruptible in MO or application). Any other illness or condition that is grounds for exclusion for the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lluis Orozco, MD
Phone
600 421 095
Email
lluis.orozco@itrt.es
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Soler Rich, MD
Phone
609 525 263
Email
robert.soler@itrt.es
Facility Information:
Facility Name
Institut de Terapia Regenerativa Tissular
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy

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