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The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients

Sponsor
Universitas Sebelas Maret (Other)
Overall Status
Completed
CT.gov ID
NCT05925647
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
7.2
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research is a clinical trial of administering mesenchymal stem cell secretome to rheumatoid arthritis patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: Messenchymal stem cell secretome
  • Drug: Placebo
 Phase 1/Phase 2

Detailed Description

This research is experimental. The research subjects were 30 rheumatoid arthritis patients. The control group received a placebo, and the treatment group received mesenchymal stem cell secretome on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th. The data collected were erythroblastic acidity, hsCRP, interlukin 6, DAS-28, and assessment of drug side effects before and after therapy. Statistical test with paired difference test with p<0.05

Study Design

Study Type:
Interventional
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 dayThis 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 Rheumatoid Arthritis Patients
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Feb 28, 2023
Actual Study Completion Date :
Mar 9, 2023

Arms and Interventions

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: Messenchymal stem cell secretome
Mesenchymal stem cell secretome obtained from Kalbe Pharma Company
Other Names:
  • Messenchymal stem cell Concitioned Media

    		•
    Placebo Comparator: Placebo

    Nacl 0,9% infusion

    Drug: Placebo
    NaCl 0,9% infusion
    Other Names:
  • NaCl 0,9% infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rheumatoid Arthritis Disease Activity [The change of Disease activity score patients at 1 months]

      Disease Activity Score 28-joint count (DAS28) before and after therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Rheumatoid Arthritis Patients
    Exclusion Criteria:
    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moewardi General Hospital Surakarta Middle Java Indonesia

    Sponsors and Collaborators

    • Universitas Sebelas Maret

    Investigators

    • Principal Investigator: Nurhasan Agung Prabowo, MD, Universitas Sebelas Maret

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Nurhasan Agung Prabowo, MD, Head of Hospital Research Unit, Universitas Sebelas Maret
    ClinicalTrials.gov Identifier:
    NCT05925647
    Other Study ID Numbers:
    • NAP06
    First Posted:
    Jun 29, 2023
    Last Update Posted:
    Jun 29, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nurhasan Agung Prabowo, MD, Head of Hospital Research Unit, Universitas Sebelas Maret
    Rheumatoid Arthritis, Messenchymal stem cell secretome
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Jun 29, 2023