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The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

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ClinicalTrials.gov Identifier: NCT05921058
Recruitment Status : Completed
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
Sponsor:
Information provided by (Responsible Party):
Arief Nurudhin, Universitas Sebelas Maret

Study Description
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Brief Summary:
This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus Drug: Secretome Drug: Placebo Phase 1 Phase 2

Detailed Description:
This research is experimental. The study was conducted on 30 SLE patient subjects. the treatment group who got the mesenchymal stem cell secretome on the 1st, 2nd day, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th days. ESR, hs-CRP, C3, C4, interlukin 6, anti-ds-DNA antibody, MEX SLEDAI score, and assessment of drug side effects before and after therapy were collected. Statistical test with paired difference test with p < 0.05
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Mesenchymal stem cell placebo and secretome using injections that are similar in shape and color
Primary Purpose: Treatment
Official Title: The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients
Actual Study Start Date : August 1, 2022
Actual Primary Completion Date : December 30, 2022
Actual Study Completion Date : March 9, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Messenchymal stem cell secretome
The hypoxic mesenchymal stem cell secretome has been developed up to chapter 7, stored at -196 C to -135 C in cryopreservation, and has passed quality tests.
 Drug: Secretome
Mesenchymal stem cell secretome obtained from Kalbe Pharma Company
Other Name: Messenchymal stem cell Concitioned Media
Placebo Comparator: Placebo
Nacl 0,9% infusion
 Drug: Placebo
NaCl 0,9% infusion
Other Name: NaCl 0,9% infusion


Outcome Measures
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Primary Outcome Measures :
  1. Lupus Disease activity [ Time Frame: Change of Lupus Disease Activity at 1 months ]
    The data collected were MEX SLEDAI score (range 0-32) before and after therapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lupus paatients

Exclusion Criteria:

  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05921058


Locations
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Indonesia
Moewardi General Hospital
Surakarta, Middle Java, Indonesia
Sponsors and Collaborators
Universitas Sebelas Maret
Investigators
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Principal Investigator: Nurhasan Agung Prabowo, MD Universitas Sebelas Maret
More Information
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Publications of Results:

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Responsible Party: Arief Nurudhin, MD. Ph.D, Universitas Sebelas Maret
ClinicalTrials.gov Identifier: NCT05921058    
Other Study ID Numbers: NAP05
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arief Nurudhin, Universitas Sebelas Maret:
Messenchymal Stem Cell Secretome
Lupus