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Covid 19Phase 2/3UCMSCNCT05132972

Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

A Phase 2/3 study testing Normoxic Allogenic UCMSC and Normal saline solution in people with Covid 19, run by Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia at 3 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is conducted to assess the efficacy and safety of stem cells as adjunctive treatment for severe COVID-19 patients. Here, we want to study whether the administration of mesenchymal stem cells are safe and able to relieve some of the COVID-19 symptoms Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Covid 19
What is being tested?
Normoxic Allogenic UCMSC and Normal saline solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
3 sitesIndonesia
Study dates
17 Jan 2021to Nov 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Man or woman age 18-75 years
  • SARS-CoV2 positive as confirmed by SARS-CoV2 RT-PCR Test
  • Diagnosed with pnumonia as confirmed by chect radiography and history of fever, coug with one of the following symptoms: RR > 30x per minute, SaO2 93%, FaO2/FiO2 300 mmHg
  • Voluntarily joined the clinical trial and has signed the informed consent form

Who cannot join

  • Pregnant and lactating woman
  • Patient who are diagnosed or have history of tumor and cancer
  • Patient whose mother or sister are diagnosed with breast or ovarian cancer
  • Level of SGPT/ALT is ≥ 5 times upper limit from normal value
  • Level of eGFR is < 30 ml/min
  • Reluctant to sign informed consent and unwilling to take the required tests
Show all 10Show fewer
  • Require invasive ventilation
  • Shock
  • Organ failure
  • Currently involve in other clinical trial, or join another clinical trial in the last 3 months

Trial locations and contacts

3 sites in 1 country.

Bintang Soetjahjo, MD PhD contact

+628122987359

bjortho@yahoo.com

Indonesia3 sites, 3 recruiting

  • Dr. Hasan Sadikin

    Bandung, West Java, 40161

    Ahmad Faried, Prof. MD, +6281320230371

    Ahmad Faried, Prof. MD

    Recruiting

  • Dr. Moewardi General Hospital

    Surakarta, Central Java, 57126

    Arief Nurudhin, MD, PhD, +6281393955596

    Arief Nurudhin, MD, PhD

    Recruiting

  • Dr. Sardjito General Hospital

    Yogyakarta, 55281

    Samekto Wibowo, Prof. MD, +628122715617

    Samekto Wibowo, Prof. MD

    Recruiting

Other trials in Indonesia

About this study

Official title: Efficacy and Safety of Normoxic Allogenic Umbilical Cord Mesenchymal Stem Cells Administered as Adjuntive Treatment to Standard Treatment in Severe Patients With COVID-19

This study is conducted to assess the efficacy and safety of stem cells as adjunctive treatment for severe COVID-19 patients. Here, we want to study whether the administration of mesenchymal stem cells are safe and able to relieve some of the COVID-19 symptoms

Read the detailed description

This is a randomized controlled trial. double-blind, multi-center clinical study conducted at three different hospitals, on 21 patients who received intervention and 21 patients who received control treatment. The purpose of this study is to evaluate the efficacy and safety of intravenous administration of normoxic allogeneic umbilical cord-derived mesenchymal stem cell (UCMSC) in the treatment group, compared to the control group who are only given standard COVID-19 treatments and normal saline infusion

Conditions
Covid 19
Being tested
Normoxic Allogenic UCMSC, Normal saline solution
Keywords
COVID19, Mesenchymal Stem Cells (MCSs), Adjuvant therapy, Indonesia
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normoxic Allogenic UCMSCBiological

    Allogenic umbilical cord-derived mesenchymal stem cell (UCMSC) from normoxic, culture condition, administered through intravenousinfusion at dose 1x10^6 cells MSC/kg body weight. The treatment will be administered three times, at three days intervals (day 0, day 3, and day 6)

  • Normal saline solutionOther

    Sterile saline solution and adminastered through intravenous infusion three times, at three day intervals (day 0, day 3, and day 6)

Study groups in NCT05132972
Study groupRoleWhat they receive
TreatmentExperimentalGroup receiving standard COVID-19 treatment and UCMSC infusion
Receives: Biological: Normoxic Allogenic UCMSC
ControlSham comparatorGroup receiving standard COVID-19 treatment and normal saline infusion
Receives: Other: Normal saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of hospital stay

    Number of days since patient was administered until discharge in hospitals

    Measured: 20 - 24 days

Secondary outcomes (2)

  1. Post-administration clinical and radiological improvement

    Chest X-ray evaluation; mMRC(Modified Medical Research Council) Dyspnea scale;

    Measured: Baseline/day-1 (-2 days), day-15 (+/- 2 days), day-22 (+/1 2 days) post randomization day

  2. Adverse Event and Serious Adverse Event Evaluation

    Evaluation of all adverse event or serious adverse event that is observed or reported by

    Measured: 20 - 24 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start17 Jan 2021
  3. Primary completionNov 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05132972
Sponsor's protocol ID
BRIN20211118a
Acronym
UCMSC
Status last verified
Nov 2021
First submitted
23 Nov 2021
Last updated
24 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Atluri S, Manchikanti L, Hirsch JA. Expanded Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) as a Therapeutic Strategy in Managing Critically Ill COVID-19 Patients: The Case for Compassionate Use. Pain Physician. 2020 Mar;23(2):E71-E83.

    PubMed 32214286

  • Richardson JB. Urban forests near municipal solid waste incinerators do not show elevated trace metal or rare earth element concentrations across three cities in the northeast USA. Environ Sci Pollut Res Int. 2020 Jun;27(17):21790-21803. doi: 10.1007/s11356-020-08439-3. Epub 2020 Apr 12.

    PubMed 32281062

  • Liang B, Chen J, Li T, Wu H, Yang W, Li Y, Li J, Yu C, Nie F, Ma Z, Yang M, Xiao M, Nie P, Gao Y, Qian C, Hu M. Clinical remission of a critically ill COVID-19 patient treated by human umbilical cord mesenchymal stem cells: A case report. Medicine (Baltimore). 2020 Jul 31;99(31):e21429. doi: 10.1097/MD.0000000000021429.

    PubMed 32756149

  • Galipeau J, Sensebe L. Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities. Cell Stem Cell. 2018 Jun 1;22(6):824-833. doi: 10.1016/j.stem.2018.05.004.

    PubMed 29859173

  • Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.

    PubMed 32085846

  • Khoury M, Cuenca J, Cruz FF, Figueroa FE, Rocco PRM, Weiss DJ. Current status of cell-based therapies for respiratory virus infections: applicability to COVID-19. Eur Respir J. 2020 Jun 4;55(6):2000858. doi: 10.1183/13993003.00858-2020. Print 2020 Jun.

    PubMed 32265310

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Normoxic Allogenic UCMSC and Normal saline solution in people with Covid 19, run by Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia at 3 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bintang Soetjahjo, MD PhD (+628122987359, bjortho@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of hospital stay (time frame: 20 - 24 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05132972, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.

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