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Study of ADRC001 (Adipose-Derived Stem Cells) for treating dry mouth (xerostomia) in patients who received radiation therapy for head and neck cancer

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating xerostomia (dry mouth) that occurs after radiation therapy in people who have survived head and neck cancer. This condition develops when radiation treatment damages the salivary glands, leading to reduced saliva production and persistent mouth dryness. The study aims to determine if injecting specially processed stem cells called Adipose Derived Regenerative Cells (ADRC001) into the salivary glands can improve saliva production.

The treatment involves receiving two injections of either ADRC001 or sterile isotone saline (placebo) directly into the salivary glands. These stem cells are derived from fat tissue and are processed in a laboratory to create a specialized cell therapy product. The treatment will be administered over a period of several months to evaluate its effectiveness in improving saliva production.

The study will monitor participants for 8 months to measure changes in their saliva production. The cell therapy being tested represents an innovative approach to treating radiation-induced dry mouth, which can significantly impact quality of life for cancer survivors. This research explores whether these stem cell injections can help restore the natural function of salivary glands that have been damaged by radiation therapy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial measurement
Your salivary flow rate will be measured to establish a starting point (baseline)
This measurement is done using a technique called sialometry, which measures how much saliva you produce naturally without stimulation
Step 2
First treatment
You will receive an injection directly into your salivary glands
The injection will contain either Culture expanded Adipose Derived Regenerative Cells (ADRC001) or sterile salt water
The treatment is administered through intraglandular injection (directly into the salivary glands)
Step 3
Four-month check
Your salivary flow rate will be measured again after 4 months
This measurement will help track any changes in your saliva production
Step 4
Second treatment
You will receive a second injection into your salivary glands
The injection will contain the same substance as your first treatment
Step 5
Final measurement
Your final salivary flow measurement will be taken at 8 months from the start of the study
This measurement will determine the overall effect of the treatment on your saliva production

Who can join the trial?

6 criteria

Previous treatment with radiotherapy (radiation treatment) for cancer in the head and neck area, specifically in the nasal sinuses, voice box (larynx), throat (pharynx), or mouth (oral cavity)
Good overall physical condition, able to carry out normal activities (WHO Performance status 0-1 means being able to do all or most daily activities independently)
Daily experience of dry mouth (xerostomia)
Specific saliva production rate between 0.05 and 0.5 milliliters per minute when measured without stimulation (UWS means unstimulated whole saliva)
Must be at least 18 years old
Must be willing and able to provide written informed consent to participate in the study

Who cannot join the trial?

15 criteria

Active cancer or history of cancer recurrence in the past 12 months
Radiation therapy to the head and neck area within the last 12 months
Current infections in the mouth or salivary glands
Severe autoimmune diseases (conditions where the body's immune system attacks its own tissues)
Uncontrolled diabetes (high blood sugar levels)
Current participation in other clinical trials
Known allergies to materials used in the treatment
Blood clotting disorders or use of blood-thinning medications
Pregnancy or breastfeeding
History of substance abuse in the past 2 years
Severe psychiatric conditions that could interfere with following study procedures
Major surgery planned during the study period
Conditions that affect saliva production not related to radiation therapy
Inability to provide informed consent
Life expectancy less than 12 months

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Rigshospitalet
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Copenhagen, Denmark

Trial locations

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Investigated drugs

Adipose-derived Mesenchymal Stem Cells (ASCs) These are stem cells extracted from fat tissue. When injected into the salivary glands, they may help repair damage caused by radiation therapy in head and neck cancer survivors. The treatment aims to improve saliva production in patients who experience dry mouth (xerostomia) after radiation therapy. The stem cells have the potential to regenerate damaged tissue and restore normal salivary gland function.

Adrc001

What is already known about the treatment

ASCs (Adipose-derived Stem Cells) – A therapeutic cellular product administered through intraglandular injection directly into the salivary glands to treat radiation-induced xerostomia (dry mouth) in head and neck cancer survivors. These stem cells, derived from fatty tissue, work by promoting tissue regeneration and reducing inflammation in damaged salivary glands, potentially restoring their natural function. ASCs are currently being investigated in clinical trials as a novel regenerative medicine approach, representing a significant advancement in treating radiation-induced salivary gland dysfunction where traditional treatments have shown limited success. This biological therapy belongs to the category of cellular therapeutics and regenerative medicine treatments.

Investigated diseases

Xerostomia
A condition characterized by dry mouth due to reduced or absent saliva production. In this case, it occurs as a consequence of radiation therapy administered to treat head and neck cancer. The condition develops when radiation damages the salivary glands, affecting their ability to produce saliva. The reduced saliva flow impacts basic oral functions and comfort. The condition can persist long-term after the completion of radiation therapy.
Head and Neck Cancer
A group of cancers that starts in the tissues of the head and neck area, including the throat, larynx, nose, sinuses, and mouth. These cancers typically begin in the squamous cells that line the moist surfaces of these regions. The disease can affect various functions including breathing, swallowing, and speech. The condition may spread to nearby tissues and lymph nodes if not addressed.