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

2024-516715-25-00 Phase I and Phase II (Integrated) - Other Ongoing, recruiting

Start 21 Jan 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other
Status Ongoing, recruiting
Participants planned 40
Countries 1
Sites 1

Sjögrens Syndrone

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 aft…

Key facts

Sponsor
Rigshospitalet
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
Trial duration
21 Jan 2025 → ongoing
Decision date (initial)
2024-10-21
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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 objectives 7

  1. • Effect on stimulated whole saliva flow rate (SFR)
  2. • Quality of the whole saliva in terms of changes in electrolytes, total protein, alpha-amylase, and salivary IgA
  3. • Safety evaluated by serious adverse events (SAE), adverse advents (AE), and deaths
  4. • Patient-reported outcomes measured by the Xerostomia Questionnaire[20], Clinical Oral Dryness score[21], and Summated Xerostomia Inventory[22]
  5. • Immune response measured by the development of donor specific antibodies
  6. • Changes in the gland morphology as assessed by ultrasound using the OMERACT US scoring system after aBM-MSCs of both parotid and submandibular glands[23]
  7. • Changes in ESSDAI and ESSPRI[24,25]

Conditions and MedDRA coding

Sjögrens Syndrone

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2023-510401-17-00 Intraglandular treatment with mesenchymal stem cells in patients with xerostomia due to Sjögrens syndrome Rigshospitalet

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. • Patients diagnosed with SS according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) classification criteria for pSS
  2. • Age above 18 years
  3. • Presence of xerostomia
  4. • UFR of minimum 0.05 ml/min and maximum 3.0 ml/min
  5. • Informed consent

Exclusion criteria 9

  1. • Currently receiving xerogenic medications such as hypertensive medications, anticholinergic medication, tricyclic antidepressants, and opioids
  2. • Have any other diseases of the salivary glands, e.g. radiation-induced xerostomia
  3. • Previous had submandibular gland surgery
  4. • Previous had treatment with any type of stem cells in the saliva glands
  5. • Are pregnant or have a planned pregnancy within the four months study period
  6. • Are breastfeeding
  7. • Have been smoking within the previous 6 months from screening visit
  8. • 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)
  9. • Have any other disease/condition judged by the investigator to be grounds for exclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

CL-AD-MSC-002

PRD11415491 · Product

Active substance
CL-AD-MSC-002
Pharmaceutical form
INJECTION
Route of administration
INTRAGLANDULAR USE
Authorisation status
Not Authorised
MA holder
REGION HOVEDSTADENS APOTEK
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo consists of sterile isotonic saline water 0,9%.

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

94 Total trials 54 Recruiting 24 Ended
Academic / Non-commercial
Sponsor organisation
Rigshospitalet
Address
Blegdamsvej 9
City
Copenhagen Oe
Postcode
2100
Country
Denmark

Scientific contact point

Organisation
Rigshospitalet
Contact name
Joachim Hansen

Public contact point

Organisation
Rigshospitalet
Contact name
Joachim Hansen

Third parties 2

OrganisationCity, countryDuties
Rigshospitalet
ORG-100002431
 Glostrup, Denmark Code 13, Code 2
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 40 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ongoing, recruiting
Rigshospitalet
Department of otorhinolaryngology, Head and Neck surgery, Inge Lehmanns Vej 7, 2100, Copenhagen Oe

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2025-01-21 2025-02-02

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) HANDOUT Xerostomia Questionaire 1
Protocol (for publication) PROTOCOL_SJOGREN_FINAL 2.0
Protocol (for publication) Questionaires REDCap_ASSIX 1
Recruitment arrangements (for publication) Patient Recruitment 2.0
Subject information and informed consent form (for publication) Brev til forsgsperson 2.0
Subject information and informed consent form (for publication) Deltagerinformation_samtykke 2.0
Synopsis of the protocol (for publication) Protocol synopsis 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-23 Denmark Acceptable
2024-10-21
 2024-10-21