Neoplasms

All Conditions

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

University Medical Center Groningen

Nervous System Diseases

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Multiple Sclerosis

Multiple Sclerosis, Chronic Progressive

Sclerosis

Neoplasm Metastasis

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Neoplastic Processes

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Intraventricular injections of Allogenic human Neural Stem Cells (hNSCs) in four different dosages (5, 10,16 or 24 millions)

Allogenic human Neural Stem Cells (hNSCs) in four different dosages (5, 10, 16 or 24 millions). hNSCs are produced by the Laboratorio Cellule Staminali of Terni according to GMP guidelines and are obtained from brain specimens of several fetal human donors from spontaneous miscarriages occurred after the 8th week after conception.

Human Neural Stem Cells

Angelo L Vescovi, PhD

This will be a phase I, open, multicenter, international study performed by 3 participating centres across two countries (Italy and Switzerland). Fifteen to 24 patients affected by SPMS will be enrolled, according to a "standard" phase I design over 18 months. All patients will enter a 3 months run in phase. Thereafter they will receive one of four different doses of allogenic hNSCs (dose A=5 millions hNSCs; dose B=10 millions hNSCs; dose C=16 millions hNSCs; dose D=24 millions hNSCs). Following hNSCs injection, all SPMS patients will receive immunosuppression with tacrolimus for 6 months. Patients will be clinically followed monthly for 1 year and then every 6 months for the 5 years following the study completion (possibly all life long).

MRI assessments will be performed monthly for the first 6 months and then every 3 months for 5 years following the study completion.

Fifteen to 24 patients affected by SPMS will be enrolled, according to a "standard" phase I design over 18 months. All patients will enter a 3 months run in phase. Thereafter they will receive one of four different doses of allogenic hNSCs (dose A=5 millions hNSCs; dose B=10 millionshNSCs; dose C=16 millions hNSCs; dose D=24 millions hNSCs).

Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients

A Phase I Multicenter Study of Allogenic, Intracerebroventricular Human Neural Stem Cells Transplantation for the Experimental Treatment of Secondary Progressive Multiple Sclerosis Patients

All IPD that underlie results in a publication

To Evaluate the Feasibility, Safety and Tolerability of intracerebroventricular injection of allogenic hNSCs

Percentage of subjects (%) with death due to procedure (mortality correlated to treatment)

this will be measured by the change of the Expanded Disability Scale (EDSS-disability score about pyramidal, cereberral, brainstem, sensory, bowel and bladder, visual, cerebral Functional Systems) during the study period.

this will be measured by the change of the the Multiple Sclerosis Functional Composite (MSFC-scores about upper extremity function, ambulation and cognitive function) during the study period.

This will be measured as the mean change of the score of the RAO Brief Repeatable Battery of Neuropsychological Test, during the study period.

Relapses will be measured by the change in EDSS scale

Relapses will be measured by the Imaging evaluations

Investigation of potential candidate biomarkers able to monitor disease activity and predict clinical course in MS (Neurofilaments)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients	NCT03282760	Secondary-progr...	Human Neural St...	18 Years - 60 Years	Casa Sollievo della Sofferenza IRCCS

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