Back to resultsThe Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Messenchymal stem cell secretome
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Messenchymal stem cell secretome
Eligibility Criteria
Inclusion Criteria: Rheumatoid Arthritis Patients Exclusion Criteria: Pregnancy
Sites / Locations
- Moewardi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Messenchymal stem cell secretome
Placebo
Arm Description
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.
Nacl 0,9% infusion
Outcomes
Primary Outcome Measures
Rheumatoid Arthritis Disease Activity
Disease Activity Score 28-joint count (DAS28) before and after therapy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05925647
Brief Title
The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients
Official Title
The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
March 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sebelas Maret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research is a clinical trial of administering mesenchymal stem cell secretome to rheumatoid arthritis patients.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Messenchymal stem cell secretome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Mesenchymal stem cell placebo and secretome using injections that are similar in shape and color
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Messenchymal stem cell secretome
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nacl 0,9% infusion
Intervention Type
Drug
Intervention Name(s)
Messenchymal stem cell secretome
Other Intervention Name(s)
Messenchymal stem cell Concitioned Media
Intervention Description
Mesenchymal stem cell secretome obtained from Kalbe Pharma Company
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NaCl 0,9% infusion
Intervention Description
NaCl 0,9% infusion
Primary Outcome Measure Information:
Title
Rheumatoid Arthritis Disease Activity
Description
Disease Activity Score 28-joint count (DAS28) before and after therapy.
Time Frame
The change of Disease activity score patients at 1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid Arthritis Patients
Exclusion Criteria:
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurhasan Agung Prabowo, MD
Organizational Affiliation
Universitas Sebelas Maret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moewardi General Hospital
City
Surakarta
State/Province
Middle Java
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34912736
Citation
Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.
Results Reference
result
PubMed Identifier
34181079
Citation
Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.
Results Reference
result
Links:
URL
https://www.banglajol.info/index.php/BJMS/article/view/51560
Description
Mesenchymal Stem Cell Conditioned Medium as Good as Methyl Prednisolone in Decreasing Levels of Interleukin 10 and The Degree of Pulmonary Vasculitis in Lupus Mice
Learn more about this trial
The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients
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