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Status unknownNCT03743155Updated Nov 16, 2018

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

A Phase 2 interventional study of mesenchymal cells in Xerostomia Due to Radiotherapy, sponsored by Institut de Terapia Regenerativa Tissular. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-11-16.

Sponsored by Institut de Terapia Regenerativa Tissular · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Phase II not controlled, open-label, prospective, single center clinical trial

Read the 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).
02

Conditions studied

  • Xerostomia Due to Radiotherapy

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    treatment with mesenchymal stem cells

    xerostomy using mesenchymal stem cells adult autologous bone marrow

    Biological: mesenchymal cells

Interventions

  • Biologicalmesenchymal 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

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 24 months

  2. Changes in the characteristics and degree of discomfort of xerostomia.

    Absolute and relative change of the score of the EVA Questionnaire

    Time frame: 24 months

  3. Sialometry results

    Absolute and relative change in the volume of saliva (ml / min) submaxillary

    Time frame: 24 months

  4. Restoration of the glandular structure.

    Changes in the glandular structure (volume) (MRI with contrast)

    Time frame: 24 months

  5. Restoration of the glandular structure.

    Changes in the glandular structure (vascularization) (MRI with contrast)

    Time frame: 24 months

  6. Restoration of the glandular structure.

    Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)

    Time frame: 24 months

  7. Measurement of submaxillary gland functionalism changes based on Gammagraphy

    Measurement of submaxillary gland functionalism changes based on Gammagraphy

    Time frame: 24 months

Secondary outcomes

  1. 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

    Time frame: 24 months

06

Study locations

1 site
  • Institut de Terapia Regenerativa Tissular
    Barcelona, 08022, Spain
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03743155
Lead sponsor
Institut de Terapia Regenerativa Tissular
Responsible party
Sponsor
First posted
Nov 16, 2018
Start date
Dec 15, 2018 (estimated)
Primary completion
May 30, 2019 (estimated)
Completion
May 30, 2021 (estimated)
Last update
Nov 16, 2018

Study contacts

Lluis Orozco, MD
Contact
lluis.orozco@itrt.es
600 421 095
Roberto Soler Rich, MD
Contact
robert.soler@itrt.es
609 525 263

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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