Phase II clinical trial to evaluate the effect and safety of MSV * in Xerostomia * adult autologous bone marrow mesenchymal stem cells

Phase 1

• Conditions: Xerostomia post radiotherapy; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]; MedDRA version: 20.0 Level: LLT Classification code 10048223 Term: Xerostomia System Organ Class: 100000004856

• Registration Number: EUCTR2018-001720-19-ES
• Lead Sponsor: Institut de Terapia Regenerativa Tissular S.L. (ITRT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-23
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 10

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified