MESRIX-SAFETY: Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03874572
Collaborator
(none)
10
2
1
80.5
5
0.1

Study Details

Study Description

Brief Summary

An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma

Condition or Disease Intervention/Treatment Phase
  • Biological: Allogeneic adipose derived stem/stromal cells
Phase 1

Detailed Description

Patients with previous oropharyngeal cancer and radiation-induced hyposalivation and xerostomia (dry mouth syndrome) will receive intraglandular injections of allogeneic adipose-derived MSCs into the submandibular and parotid glands. The trial will be Good Clinical Practice (GCP) Monitored. From healthy donors, MSCs will be produced at a Good Manufacturing Practice (GMP) Facility.

The patients will be followed for four months for safety, tolerability, and efficacy registration. Changes in quality of life, unstimulated, and stimulated whole saliva flow rate, salivary gland function will be assessed. Immune response towards receiving allogeneic MSCs will be evaluated in plasma and saliva. Changes in the composition and quality of the whole saliva will be investigated.

Saliva from the participants will altså be compared to saliva from ten healthy controls.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Open Label Study Evaluating the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia in Previous Oropharynx Cancer Patients
Actual Study Start Date :
Mar 18, 2019
Actual Primary Completion Date :
Jun 22, 2020
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Allogeneic mesenchymal stem/stromal cell therapy

Treatment with intra-glandular Injections of allogeneic adipose derived stem cells

Biological: Allogeneic adipose derived stem/stromal cells
Culture expanded allogeneic adipose derived stem/stromal cells

Outcome Measures

Primary Outcome Measures

  1. Safety: Number of patients with serious adverse events [4 months]

    Registration of number of patients with serious adverse events in a 4 months follow-up period

Secondary Outcome Measures

  1. Immune reponse :Development of donor specific antibodies [4 months]

    Registration of development of tissue antibodies towards donor cells

  2. Efficacy: Change in Unstimulated Whole Salivary flow rate [4 months]

    Unstimulated whole saliva flow rate is assessed by sialometry

  3. Efficacy: Change in Stimulated Whole Salivary flow rate [4 months]

    Unstimulated whole saliva flow rate is assessed by sialometry

  4. Efficacy: Change in quality of life [4 months]

    Change in quality of life evaluted by QLQ-H&N-35 and XQ questionnaires

  5. Efficacy: Salivary gland function [4 months]

    Assessed by salivary gland 99mTc scintigraphy

  6. Efficacy: Change in Saliva composition [4 months]

    Change in inorganic saliva composition

  7. Efficacy: Change in Saliva Proteomics [4 months]

    Change in Saliva proteomics

  8. Efficacy: Change in RNA in Saliva [4 months]

    Change in RNA in saliva

  9. Immune reponse [4 months]

    Reactions in plasma and saliva will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age between 18-75 years

  2. Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017)

  3. 2 years' follow-up without recurrence

  4. Clinically reduced salivation and hyposalivation, evaluated by a screening

  5. Unstimulated salivary flow rate between 0.2mL/min and 0.05mL/min

  6. Grade 2-3 xerostomia (CTCAEv5.0)

  7. WHO Performance status (PS) 0-1

  8. Informed consent

Exclusion Criteria:
  1. Any cancer in the previous 4 years (not including OPSCC and basocellular carcinomas)

  2. Xerogenic medications

  3. Penicillin or Streptomycin allergy

  4. Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis

  5. Previous parotid or submandibular gland surgery

  6. Previous treatment with any type of stem cells

  7. Breastfeeding, Pregnancy or planned pregnancy within the next 2 years

  8. Smoking within the previous 6 months.

  9. Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines3)

  10. Any other disease/condition judged by the investigator to be grounds for exclusion

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen Copenhagen Denmark 2100
2 Department of Otolaryngology, Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Charlotte Lynggaard, MD, Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charlotte Lynggaard, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT03874572
Other Study ID Numbers:
  • CVB2018-2
  • 2018-003856-19
First Posted:
Mar 14, 2019
Last Update Posted:
Jan 29, 2021
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Charlotte Lynggaard, Principal Investigator, Rigshospitalet, Denmark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 29, 2021