NCT05921058

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

March 9, 2023

Last Update Submit

June 25, 2023

Conditions

Lupus Erythematosus

Keywords

Messenchymal Stem Cell SecretomeLupus

Outcome Measures

Primary Outcomes (1)

  • Lupus Disease activity

    The data collected were MEX SLEDAI score (range 0-32) before and after therapy.

    Change of Lupus Disease Activity 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: Secretome

Placebo

PLACEBO COMPARATOR

Nacl 0,9% infusion

Drug: Placebo

Interventions

SecretomeDRUG

Mesenchymal stem cell secretome obtained from Kalbe Pharma Company

Also known as: Messenchymal stem cell Concitioned Media
Messenchymal stem cell secretome
PlaceboDRUG

NaCl 0,9% infusion

Also known as: NaCl 0,9% infusion
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Lupus paatients

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 34912736RESULT

  • 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: 34181079RESULT

MeSH Terms

Interventions

Secretome

Intervention Hierarchy (Ancestors)

MetabolomeMetabolism

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
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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Ph.D

Study Record Dates

First Submitted

March 9, 2023

First Posted

June 27, 2023

Study Start

August 1, 2022

Primary Completion

December 30, 2022

Study Completion

March 9, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)