Clinical trial • Not applicable • Other

CL-AD-MSC-002 for Sjögren's syndrome | Xerostomia

Not applicable trial of CL-AD-MSC-002 for Sjögren's syndrome | Xerostomia.

Overview

Trial Therapeutic Area
Other
Trial Disease
Sjögren's syndrome | Xerostomia
Trial Stage
Not applicable
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
23-07-2024
First CTIS Authorization Date
21-10-2024

Trial design

CL-AD-MSC-002 (injection, intraglandular use) versus Placebo ("Placebo consists of sterile isotonic saline water 0,9%."); dose and schedule not specified in the record.-controlled Not applicable trial in Denmark.

Comparator
CL-AD-MSC-002 (injection, intraglandular use) versus Placebo ("Placebo consists of sterile isotonic saline water 0,9%."); dose and schedule not specified in the record.
Target Sample Size
40

Eligibility

Recruits 40 No vulnerable populations selected (isVulnerablePopulationSelected = false). Participants are adults (Age above 18 years) and informed consent is required..

Pregnancy Exclusion
• Are pregnant or have a planned pregnancy within the four months study period
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected = false). Participants are adults (Age above 18 years) and informed consent is required.

Inclusion criteria

  • {"criterion_text":"- •\tPatients diagnosed with SS according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) classification criteria for pSS"}
  • {"criterion_text":"- •\tAge above 18 years"}
  • {"criterion_text":"- •\tPresence of xerostomia"}
  • {"criterion_text":"- •\tUFR of minimum 0.05 ml/min and maximum 3.0 ml/min"}
  • {"criterion_text":"- •\tInformed consent"}

Exclusion criteria

  • {"criterion_text":"- •\tCurrently receiving xerogenic medications such as hypertensive medications, anticholinergic medication, tricyclic antidepressants, and opioids"}
  • {"criterion_text":"- •\tHave any other diseases of the salivary glands, e.g. radiation-induced xerostomia"}
  • {"criterion_text":"- •\tPrevious had submandibular gland surgery"}
  • {"criterion_text":"- •\tPrevious had treatment with any type of stem cells in the saliva glands"}
  • {"criterion_text":"- •\tAre pregnant or have a planned pregnancy within the four months study period"}
  • {"criterion_text":"- •\tAre breastfeeding"}
  • {"criterion_text":"- •\tHave been smoking within the previous 6 months from screening visit"}
  • {"criterion_text":"- •\tHave 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)"}
  • {"criterion_text":"- •\tHave any other disease/condition judged by the investigator to be grounds for exclusion"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as the change in the unstimulated whole saliva flow rate (UFR) from baseline to 4 months after treatment."}

Recruitment

Planned Sample Size
40
Recruitment Window Months
57
Consent Approach
Informed consent is required (document 'Deltagerinformation_samtykke' listed). Participants are adults (age above 18). No details on assent, consent by proxy, or available languages are provided in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Denmark

Earliest CTIS Part Ii Submission Date
22-09-2024
Latest Decision Or Authorization Date
21-10-2024
Processing Time Days
29
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Rigshospitalet
Department Name
Department of otorhinolaryngology, Head and Neck surgery
Principal Investigator Name
Joachim Joachim Hansen
Principal Investigator Email
joachim.hansen.01@regionh.dk
Contact Person Name
Joachim Joachim Hansen
Contact Person Email
joachim.hansen.01@regionh.dk
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Rigshospitalet","duties_or_roles":"Codes: 13, 2","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"Codes: 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
CL-AD-MSC-002
Active Substance
CL-AD-MSC-002
Modality
Cell therapy
Routes Of Administration
INTRAGLANDULAR USE
Route
INTRAGLANDULAR USE
Investigational Product Name
Placebo consists of sterile isotonic saline water 0,9%.
Modality
Other

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