NCT03743155

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

November 5, 2018

Last Update Submit

November 14, 2018

Conditions

Xerostomia Due to Radiotherapy

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (1)

  • AEs and SAEs

    24 months

Study Arms (1)

treatment with mesenchymal stem cells

EXPERIMENTAL

xerostomy using mesenchymal stem cells adult autologous bone marrow

Biological: mesenchymal cells

Interventions

mesenchymal cellsBIOLOGICAL

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

treatment with mesenchymal stem cells

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients from 18 to 75 years old of both sexes.
  • Biochemical analysis without significant alterations which could contraindicate the treatment.
  • Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
  • years of follow-up without recurrence.
  • 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.
  • Grade 1-3 xerostomy as assessed by the grading scale.
  • The patient is able to understand the nature of the study.
  • Written informed consent of the patient

You may not qualify if:

  • Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
  • Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
  • 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.
  • Xerogenic medication in progress.
  • Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
  • Local infection.
  • Pregnancy or pregnancy planned within the next 2 years.
  • Breastfeeding.
  • Treatment with anticoagulants (not interruptible in MO or application).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Terapia Regenerativa Tissular

Barcelona, 08022, Spain

Location

Central Study Contacts

Lluis Orozco, MD

CONTACT

600 421 095lluis.orozco@itrt.es

Roberto Soler Rich, MD

CONTACT

609 525 263robert.soler@itrt.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single arm due to not alternative treatment exist
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 16, 2018

Study Start

December 15, 2018

Primary Completion

May 30, 2019

Study Completion

May 30, 2021

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations

ES(1)