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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03874572
Other study ID # CVB2018-2
Secondary ID 2018-003856-19
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 18, 2019
Est. completion date December 1, 2025

Study information

Verified date September 2020
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date December 1, 2025
Est. primary completion date June 22, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Denmark Department of Otolaryngology, Rigshospitalet Copenhagen
Denmark Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Immune reponse :Development of donor specific antibodies Registration of development of tissue antibodies towards donor cells 4 months
Secondary Efficacy: Change in Unstimulated Whole Salivary flow rate Unstimulated whole saliva flow rate is assessed by sialometry 4 months
Secondary Efficacy: Change in Stimulated Whole Salivary flow rate Unstimulated whole saliva flow rate is assessed by sialometry 4 months
Secondary Efficacy: Change in quality of life Change in quality of life evaluted by QLQ-H&N-35 and XQ questionnaires 4 months
Secondary Efficacy: Salivary gland function Assessed by salivary gland 99mTc scintigraphy 4 months
Secondary Efficacy: Change in Saliva composition Change in inorganic saliva composition 4 months
Secondary Efficacy: Change in Saliva Proteomics Change in Saliva proteomics 4 months
Secondary Efficacy: Change in RNA in Saliva Change in RNA in saliva 4 months
Secondary Immune reponse Reactions in plasma and saliva will be assessed 4 months
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