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AzTrials

Covid19Phase 1/2NCT05019287

Menstrual Blood Stem Cells in Severe Covid-19

A Phase 1/2 study testing Allogeneic human menstrual blood stem cells secretome and Intravenous saline injection in people with Covid19 and Cytokine Storm, run by Avicenna Research Institute at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of menstrual blood stem cells. The improvement in the clinical, laboratory and radiological manifestations will be evaluated in treated patients compared with the control group. Read more about this study

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Covid19, Cytokine Storm
What is being tested?
Allogeneic human menstrual blood stem cells secretome and Intravenous saline injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
1 siteIran
Study dates
17 Apr 2021to 9 Jun 2021
Phase
Phase 1/2
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 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients whose clinical and laboratory test results have a positive diagnosis of Covid-19.
  • Patients who are willing to participate as subjects in the study by signing the informed content.
  • Diagnosed with severe pneumonia of COVID: respiratory distress, RR >30 times/min; resting oxygen saturation of 90% or less; arterial partial pressure of oxygen / oxygen concentration ≤300mmHg; Pulmonary infiltration more than 50% in 24 to 48 hours
  • SARS-CoV-2 nucleic acid test was positive.

Who cannot join

  • History of drug reactions or allergies
  • Pneumonia caused by bacteria, Mycoplasma, Chlamydia, Legionella, fungi, or other viruses
  • Airway obstruction due to lung cancer or unknown factors
  • Carcinoid syndrome
  • History of epilepsy and long-term use of anticonvulsant drugs during the last 3 years
  • History of long-term use of immunosuppressive drugs
Show all 15Show fewer
  • History of chronic respiratory illness that requires long-term oxygen therapy
  • The patient is on blood or peritoneal dialysis
  • Creatinine clearance <15 ml / min
  • Moderate to severe liver disease (Child-Pugh score> 12)
  • History of deep vein thrombosis (DVT) or pulmonary embolism over the past 3 years
  • Being under ECMO or high-frequency oscillatory ventilation support
  • Diagnostic of HIV, hepatitis B, and syphilis
  • Pregnant or lactating women
  • Lack of consciousness and inability to provide informed consent by the patient

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Avicenna Research Institute

    Tehran

Other trials in Iran

About this study

Official title: Safety and Efficacy Study of Allogeneic Human Menstrual Blood Stem Cells Secretome to Treat Severe Covid-19 Patients, Clinical Trial Phase I&II

In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of menstrual blood stem cells. The improvement in the clinical, laboratory and radiological manifestations will be evaluated in treated patients compared with the control group.

Read the detailed description

The devastating effect of severe acute respiratory syndrome coronavirus-2 (SARS COV-2) infection is caused by a robust cytokine storm that leads to lung tissue damage. Several studies have found that the severity of the disease is correlated with the release of excessive proinflammatory cytokines, such as IL-1, IL-6, IL-12, IFN-γ, and TNF-α, preferentially targeting lung tissue. This finding was confirmed by the high level of plasma cytokines found in the most severe COVID-19 patients associated with extensive lung damage. As a result, it is essential to find an effective treatment option to control the devastating cytokine storm of COVID-19 and regenerate the damaged lung. Although mesenchymal stem cells are a powerful tool for clinical applications, they have limits in terms of administration, safety, and variability of therapeutic response. It is interesting to note that the MSC secretome composed of cytokines, chemokines, growth factors, proteins, and extracellular vesicles could be a valid alternative to their use. It is not only easier to preserve, transfer and produce the secretome, but also safer to administer.

Previous studies reported that the hypoxic condition of MSCs could enhance the release of their active soluble molecules known as Secretome-MSCs (S-MSCs), such as IL-10 and TGF-β that useful in alleviating inflammation. Moreover, they could also increase the expression of growth factors such as VEGF and PDGF that accelerate lung injury improvement. These active molecules could potentially serve as a biological therapeutic agent for treating the severe SARS-CoV-2 infection. According to recent studies, we successfully isolated the S-MSCs from their culture medium using tangential flow filtration (TFF) strategy with several molecular weight cut-off category. This study investigated the clinical outcomes of severe COVID-19 patients with several comorbidities treated with S-MSCs in Indonesia.

Being tested
Allogeneic human menstrual blood stem cells secretome, Intravenous saline injection
Keywords
mesenchymal stem cells, menstrual blood stem cell, secretome, covid-19
Medical subject headings
COVID-19, Cytokine Release Syndrome

What participants receive

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

  • Allogeneic human menstrual blood stem cells secretomeBiological

    This COVID-19 Study intervention consists of Intravenous Allogeneic human menstrual blood stem cell (MenSC) secretome injection in addition to standard care. The MenSC were characterized as CD90+, CD73+, CD105+, and CD45-based on multiparameter flow cytometry.

  • Intravenous saline injectionOther

    Intravenous saline injection in addition to standard care

Study groups in NCT05019287
Study groupRoleWhat they receive
Menstrual blood stem cell secretome groupExperimentalIntravenous Allogeneic Menstrual Blood Stem Cells Secretome injection+Routine treatment
Receives: Biological: Allogeneic human menstrual blood stem cells secretome
Control groupPlacebo comparatorIntravenous saline injection (Placebo)+Routine treatment
Receives: Other: Intravenous saline injection

What is being measured

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

  1. Adverse reactions incidence

    The proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.

    Measured: Day 0 - 28

  2. Time to clinical improvement

    Days from administration of the Investigational Product for improvement

    Measured: Day 0 - 28

Secondary outcomes (8)

  1. Assessment of serum CRP (mg/L) levels

    To evaluate the anti-inflammatory effect of the proposed treatment an assessment of the inflammatory markers

    Measured: Days 0, 5, 10, 14, and 28

  2. Assessment of serum LDH (U/L) levels

    To evaluate the anti-inflammatory effect of the proposed treatment an assessment of the inflammatory markers

    Measured: Days 0, 5, 10, 14, and 28

  3. Assessment of serum Ferritin (ng/ml) levels

    To evaluate the anti-inflammatory effect of the proposed treatment an assessment of the inflammatory markers

    Measured: Days 0, 5, 10, 14, and 28

  4. Assessment of serum D-dimer (microgr/ml) levels

    To evaluate the anti-inflammatory effect of the proposed treatment an assessment of the inflammatory markers

    Measured: Days 0, 5, 10, 14, and 28

  5. Immunological changes on CD4+ T and CD8+ T

    Evaluate immune system improvement with flow cytometry to analyze patients' immune cells

    Measured: Days 0, 5, 10, 14, and 28

  6. Lung Involvement

    Side effects measured by Chest Readiograph Side effects measured by Chest Readiograph

    Measured: Day 0 - 28

  7. Changes in Inflammatory cytokine IL 6

    To assess the anti-inflammatory effect of the proposed treatment an assessment of the levels of IL6 in plasma.

    Measured: Days 0, 5, 10, 14, and 28

  8. Changes in anti-Inflammatory cytokine IL10

    To assess the anti-inflammatory effect of the proposed treatment an assessment of the levels of IL10 in plasma.

    Measured: Days 0, 5, 10, 14, and 28

Timeline

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

  1. First posted24 Aug 2021
  2. Study start17 Apr 2021
  3. Primary completion21 May 2021
  4. Study completion9 Jun 2021

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1. Biological: allogeneic human menstrual blood stem cells secretome Intravenous injection of 5 ml menstrual blood stem cells secretome on day 1, day 2, day 3, day 4, and day 5, based on the routine treatment of COVID-19 2. Other: Intravenous saline injection (Placebo) Intravenous injection of 5ml of 0.9% saline on day 1, day 2, day 3, day 4, and day 5, based on the routine treatment of COVID-19
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05019287
Sponsor's protocol ID
990308-026
Other IDs
99/3436
Status last verified
Aug 2021
First submitted
3 Jul 2021
Last updated
2 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fathi-Kazerooni M, Fattah-Ghazi S, Darzi M, Makarem J, Nasiri R, Salahshour F, Dehghan-Manshadi SA, Kazemnejad S. Safety and efficacy study of allogeneic human menstrual blood stromal cells secretome to treat severe COVID-19 patients: clinical trial phase I & II. Stem Cell Res Ther. 2022 Mar 7;13(1):96. doi: 10.1186/s13287-022-02771-w.

    PubMed 35255966

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogeneic human menstrual blood stem cells secretome and Intravenous saline injection in people with Covid19 and Cytokine Storm, run by Avicenna Research Institute at 1 site in Iran.

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 15 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: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse reactions incidence (time frame: Day 0 - 28). The study lists 2 primary outcomes in all. 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 NCT05019287, which also lists 1 linked publication.

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 2 Sep 2021.

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