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

Xerostomia Due to Radiotherapy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03743155
• Other study ID #: XRS-ITRT-2018
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 15, 2018
• Est. completion date: May 30, 2021

Study information

• Verified date: November 2018
• Source: Institut de Terapia Regenerativa Tissular
• Contact: Lluis Orozco, MD
• Phone: 600 421 095
• Email: lluis.orozco[@]itrt.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Xerostomia
• Xerostomia Due to Radiotherapy

Intervention

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

Locations

Country	Name	City	State
Spain	Institut de Terapia Regenerativa Tissular	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Terapia Regenerativa Tissular

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 months
Primary	Changes in the characteristics and degree of discomfort of xerostomia.	Absolute and relative change of the score of the EVA Questionnaire	24 months
Primary	Sialometry results	Absolute and relative change in the volume of saliva (ml / min) submaxillary	24 months
Primary	Restoration of the glandular structure.	Changes in the glandular structure (volume) (MRI with contrast)	24 months
Primary	Restoration of the glandular structure.	Changes in the glandular structure (vascularization) (MRI with contrast)	24 months
Primary	Restoration of the glandular structure.	Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)	24 months
Primary	Measurement of submaxillary gland functionalism changes based on Gammagraphy	Measurement of submaxillary gland functionalism changes based on Gammagraphy	24 months
Secondary	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	24 months