Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

ID
Name
NAP05
Description
This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.
Trial arms
Trial start
2022-08-01
Estimated PCD
2022-12-30
Trial end
2023-03-09
Status
Completed
Phase
Early phase I
Treatment
Secretome
Mesenchymal stem cell secretome obtained from Kalbe Pharma Company
Arms:
Messenchymal stem cell secretome
Other names:
Messenchymal stem cell Concitioned Media
Placebo
NaCl 0,9% infusion
Arms:
Placebo
Other names:
NaCl 0,9% infusion
Size
15
Primary endpoint
Lupus Disease activity
Change of Lupus Disease Activity at 1 months
Eligibility criteria
Inclusion Criteria: * Lupus paatients Exclusion Criteria: * Pregnancy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Mesenchymal stem cell placebo and secretome using injections that are similar in shape and color', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2023-06-27

1 organization

1 product

1 drug

1 indication

Organization
Universitas Sebelas Maret
Product
Secretome
Indication
Lupus Erythematosus
Drug
Varlilumab