The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients

NCT05925647 | Completed Phase 1 DMC

• 1 other identifier: NAP06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Messenchymal stem cell secretome

Outcome Measures

Primary Outcomes (1)

• Rheumatoid Arthritis Disease Activity

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

  The change of Disease activity score patients at 1 months

Study Arms (2)

Messenchymal stem cell secretome

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Nacl 0,9% infusion

Drug: Placebo

Interventions

Messenchymal stem cell secretome DRUG

Mesenchymal stem cell secretome obtained from Kalbe Pharma Company

Also known as: Messenchymal stem cell Concitioned Media

Messenchymal stem cell secretome

Placebo DRUG

NaCl 0,9% infusion

Also known as: NaCl 0,9% infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Rheumatoid Arthritis Patients

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

Moewardi General Hospital

Surakarta, Middle Java, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 34912736 RESULT

• 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.

  PMID: 34181079 RESULT

Related Links

• 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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nurhasan Agung Prabowo, MD

  Universitas Sebelas Maret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Mesenchymal stem cell placebo and secretome using injections that are similar in shape and color
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hospital Research Unit

Model Details: 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

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: June 29, 2023
• Study Start: August 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 9, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)