Intraglandular treatment with adipose derived mesenchymal stem cells in patients with xerostomia due to Sjögrens syndrome (ASSIX)

Phase 1/2

Recruiting

Conditions: Sjögrens Syndrone

Registration Number: 2024-516715-25-00

Lead Sponsor: Rigshospitalet

Brief Summary: The primary objective of this study is to investigate the effectiveness of injection of adipose derived mesenchymal stem cells in the submandibular glands compared to injection of placebo on the salivary gland function measured as the change in the unstimulated whole saliva flow rate (UFR) from baseline to 4 months after treatment in patients with orimary Sjögren Syndrome related xerostomia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

• Patients diagnosed with SS according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) classification criteria for pSS

• Age above 18 years

• Presence of xerostomia

• UFR of minimum 0.05 ml/min and maximum 3.0 ml/min

• Informed consent

Exclusion Criteria

• Currently receiving xerogenic medications such as hypertensive medications, anticholinergic medication, tricyclic antidepressants, and opioids

• Have any other diseases of the salivary glands, e.g. radiation-induced xerostomia

• Previous had submandibular gland surgery

• Previous had treatment with any type of stem cells in the saliva glands

• Are pregnant or have a planned pregnancy within the four months study period

• Are breastfeeding

• Have been smoking within the previous 6 months from screening visit

• Have a current alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines)

• Have any other disease/condition judged by the investigator to be grounds for exclusion

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to investigate the effectiveness of injection of adipose derived mesenchymal stem cells in the submandibular glands compared to injection of placebo on the salivary gland function measured as the change in the unstimulated whole saliva flow rate (UFR) from baseline to 4 months after treatment in patients with orimary Sjögren Syndrome related xerostomia.		The primary objective of this study is to investigate the effectiveness of injection of adipose derived mesenchymal stem cells in the submandibular glands compared to injection of placebo on the salivary gland function measured as the change in the unstimulated whole saliva flow rate (UFR) from baseline to 4 months after treatment in patients with orimary Sjögren Syndrome related xerostomia.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Rigshospitalet
🇩🇰
Copenhagen Oe, Denmark
Rigshospitalet
🇩🇰Copenhagen Oe, Denmark
Joachim Joachim Hansen
Site contact
+4523312552
joachim.hansen.01@regionh.dk