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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516715-25-00

Enrollment

Registered

2024-10-21

Start date

2025-01-21

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjögrens Syndrone

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.

Interventions

DRUGCL-AD-MSC-002

DRUGPlacebo consists of sterile isotonic saline water 0

DRUG9%.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026