NCT03874572

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

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_1

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

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

March 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2020

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 29, 2021

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

March 12, 2019

Last Update Submit

January 27, 2021

Conditions

Xerostomia Due to RadiotherapyHyposalivationXerostomiaOropharynx CancerSalivary Gland DiseasesDry MouthMesenchymal Stem CellsMesenchymal Stromal CellsStem Cells

Keywords

Xerostomia Due to Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Safety: Number of patients with serious adverse events

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

    4 months

Secondary Outcomes (9)

  • Immune reponse :Development of donor specific antibodies

    4 months

  • Efficacy: Change in Unstimulated Whole Salivary flow rate

    4 months

  • Efficacy: Change in Stimulated Whole Salivary flow rate

    4 months

  • Efficacy: Change in quality of life

    4 months

  • Efficacy: Salivary gland function

    4 months

  • +4 more secondary outcomes

Study Arms (1)

Allogeneic mesenchymal stem/stromal cell therapy

EXPERIMENTAL

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

Biological: Allogeneic adipose derived stem/stromal cells

Interventions

Allogeneic adipose derived stem/stromal cellsBIOLOGICAL

Culture expanded allogeneic adipose derived stem/stromal cells

Allogeneic mesenchymal stem/stromal cell therapy

Eligibility Criteria

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

You may qualify if:

  • Age between 18-75 years
  • Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017)
  • years' follow-up without recurrence
  • Clinically reduced salivation and hyposalivation, evaluated by a screening
  • Unstimulated salivary flow rate between 0.2mL/min and 0.05mL/min
  • Grade 2-3 xerostomia (CTCAEv5.0)
  • WHO Performance status (PS) 0-1
  • Informed consent

You may not qualify if:

  • Any cancer in the previous 4 years (not including OPSCC and basocellular carcinomas)
  • Xerogenic medications
  • Penicillin or Streptomycin allergy
  • Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis
  • Previous parotid or submandibular gland surgery
  • Previous treatment with any type of stem cells
  • Breastfeeding, Pregnancy or planned pregnancy within the next 2 years
  • Smoking within the previous 6 months.
  • Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen

Copenhagen, 2100, Denmark

Location

Department of Otolaryngology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

XerostomiaOropharyngeal NeoplasmsSalivary Gland Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Charlotte Lynggaard, MD

    Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 14, 2019

Study Start

March 18, 2019

Primary Completion

June 22, 2020

Study Completion

December 1, 2025

Last Updated

January 29, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)