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The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients

NCT ID: NCT05925647

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-03-09

Brief Summary

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

Detailed Description

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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

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis, Messenchymal stem cell secretome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Mesenchymal stem cell placebo and secretome using injections that are similar in shape and color

Study Groups

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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.

Group Type EXPERIMENTAL

Messenchymal stem cell secretome

Intervention Type DRUG

Mesenchymal stem cell secretome obtained from Kalbe Pharma Company

Placebo

Nacl 0,9% infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NaCl 0,9% infusion

Interventions

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Messenchymal stem cell secretome

Mesenchymal stem cell secretome obtained from Kalbe Pharma Company

Intervention Type DRUG

Placebo

NaCl 0,9% infusion

Intervention Type DRUG

Other Intervention Names

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Messenchymal stem cell Concitioned Media NaCl 0,9% infusion

Eligibility Criteria

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Inclusion Criteria

* Rheumatoid Arthritis Patients

Exclusion Criteria

* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitas Sebelas Maret

OTHER

Sponsor Role lead

Responsible Party

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Nurhasan Agung Prabowo, MD

Head of Hospital Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurhasan Agung Prabowo, MD

Role: PRINCIPAL_INVESTIGATOR

Universitas Sebelas Maret

Locations

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Moewardi General Hospital

Surakarta, Middle Java, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type RESULT
PMID: 34912736 (View on PubMed)

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.

Reference Type RESULT
PMID: 34181079 (View on PubMed)

Related Links

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https://www.banglajol.info/index.php/BJMS/article/view/51560

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

Other Identifiers

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NAP06

Identifier Type: -

Identifier Source: org_study_id