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

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ClinicalTrials.gov Identifier: NCT03743155
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Institut de Terapia Regenerativa Tissular

Tracking Information
First Submitted Date  ICMJE November 5, 2018
First Posted Date  ICMJE November 16, 2018
Last Update Posted Date November 16, 2018
Estimated Study Start Date  ICMJE December 15, 2018
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire [ Time Frame: 24 months ]
    Absolute and relative change of the score of the OHIP Questionnaire (OHIP-14-sp)
  • Changes in the characteristics and degree of discomfort of xerostomia. [ Time Frame: 24 months ]
    Absolute and relative change of the score of the EVA Questionnaire
  • Sialometry results [ Time Frame: 24 months ]
    Absolute and relative change in the volume of saliva (ml / min) submaxillary
  • Restoration of the glandular structure. [ Time Frame: 24 months ]
    Changes in the glandular structure (volume) (MRI with contrast)
  • Restoration of the glandular structure. [ Time Frame: 24 months ]
    Changes in the glandular structure (vascularization) (MRI with contrast)
  • Restoration of the glandular structure. [ Time Frame: 24 months ]
    Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)
  • Measurement of submaxillary gland functionalism changes based on Gammagraphy [ Time Frame: 24 months ]
    Measurement of submaxillary gland functionalism changes based on Gammagraphy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
AEs and SAEs [ Time Frame: 24 months ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
single arm due to not alternative treatment exist
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Xerostomia Due to Radiotherapy
Intervention  ICMJE Biological: mesenchymal cells
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
Study Arms  ICMJE Experimental: treatment with mesenchymal stem cells
xerostomy using mesenchymal stem cells adult autologous bone marrow
Intervention: Biological: mesenchymal cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2021
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lluis Orozco, MD 600 421 095 lluis.orozco@itrt.es
Contact: Roberto Soler Rich, MD 609 525 263 robert.soler@itrt.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03743155
Other Study ID Numbers  ICMJE XRS-ITRT-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Institut de Terapia Regenerativa Tissular
Study Sponsor  ICMJE Institut de Terapia Regenerativa Tissular
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut de Terapia Regenerativa Tissular
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP