Neoplasms

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Head and Neck Neoplasms

Submandibular Gland Stem Cell Transplantation

Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy

R.J.H.M. Steenbakkers, MD, PhD

R.J.H.M. Steenbakkers, MD,PhD

This study is a phase I safety and feasibility study to treat head and neck cancer patients with autologous salivary gland stem cell transplantation after postoperative (chemo)radiotherapy.

Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy

The number of adverse events (AE), serious adverse events (SAE) or suspected unexpected adverse reactions (SUSAR) after autologous salivary stem cell transplantation. All possible adverse events will be scored according to the definitions of the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0).

The salivary flow rate of the remaining submandibular gland will be recorded.

Unstimulated whole saliva, paraffin stimulated whole saliva and 5% citric acid stimulated parotid and submandibular/sublingual saliva measurements.

Patient-rated outcome measures including various side effects related to the postoperative (chemo)radiation and Quality of Life (QoL) using internationally validated questionnaires.

Locoregional control is defined as the number of patients with recurrent disease within or adjacent to the primary tumor site and regional lymph nodes after postoperative (chemo)radiation, assessed by pathology and/or oncologic imaging (CT, MRI or PET).

The rate of water diffusion in remaining submandibular gland derived from DWI/DTI-MRI.

The amount of prostate specific membrane antigen (PSMA) in the remaining submandibular gland derived from PET-CT

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Submandibular Gland Stem Cell Transplantation	NCT04593589	Head and Neck C...	Submandibular G...	18 Years -	University Medical Center Groningen
Submandibular Gland Stem Cell Transplantation	NCT04593589	Head and Neck C...	Submandibular G...	18 Years -	University Medical Center Groningen

Spots Global Cancer Trial Database for submandibular gland stem cell transplantation