Allogeneic Mesenchymal Stem Cells for Radiation-induced H... | NCT03874572

Studies
Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth

NCT03874572

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Jan 29, 2021Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

Xerostomia Due to Radiotherapy
Hyposalivation
Xerostomia
Oropharynx Cancer
Salivary Gland Diseases
Dry Mouth
Mesenchymal Stem Cells
Mesenchymal Stromal Cells
Stem Cells

Interventions

Allogeneic adipose derived stem/stromal cells

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2018-003856-19	EudraCT Number

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2019Actual

Primary Completion Date

Jun 22, 2020Actual

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Mar 12, 2019

First Submission Date that Met QC Criteria

Mar 12, 2019

First Posted Date

Mar 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2021

Last Update Posted Date

Jan 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Allogeneic adipose derived stem/stromal cells	Biological	Culture expanded allogeneic adipose derived stem/stromal cells	Allogeneic mesenchymal stem/stromal cell therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Immune reponse :Development of donor specific antibodies	Registration of development of tissue antibodies towards donor cells	4 months
Efficacy: Change in Unstimulated Whole Salivary flow rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18-75 years
Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017)
2 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charlotte Lynggaard, MD	Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen		Copenhagen		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010608	Pharyngeal Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D014987	Xerostomia
D009959	Oropharyngeal Neoplasms
D012466	Salivary Gland Diseases