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

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

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

Study Overview

• Status: Unknown
• Conditions: Xerostomia Due to Radiotherapy
• Intervention / Treatment: Biological: mesenchymal cells

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: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Institut de Teràpia Regenerativa Tissular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: treatment with mesenchymal stem cells; xerostomy using mesenchymal stem cells adult autologous bone marrow

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut de Terapia Regenerativa Tissular

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2018
• Primary Completion (Anticipated): May 30, 2019
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: XRS-ITRT-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No