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COVID-19 PneumoniaEarly Phase 1NCT05787288

A Clinical Study on Safety and Effectiveness of Mesenchymal Stem Cell Exosomes for the Treatment of COVID-19.

A Early Phase 1 study testing Extracellular Vesicles from Mesenchymal Stem Cells in people with COVID-19 Pneumonia, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

This clinical study aims to investigate the safety and efficacy of nebulized inhalation of extracellular vesicles derived from mesenchymal stem cells combined with standard therapy for COVID-19-infected individuals. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
Extracellular Vesicles from Mesenchymal Stem Cells
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
1 siteChina
Study dates
23 Jan 2023to 23 Jan 2025
Phase
Early Phase 1
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

  • Voluntary participation of the patient and signing of the informed consent form; (b) The age of the patient at the time of signing the informed consent form should be ≥18 years old and ≤75 years old, regardless of gender; (c) The patient meets the criteria for moderate and severe patients with COVID-19 infection in China's "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10)", as follows:
  • Moderate: continued fever >3 days and/or cough, dyspnea, or other symptoms, but respiratory rate (RR) <30 breaths/min, and oxygen saturation (SpO2) >93% at rest when inhaling air. Characteristic imaging manifestations of COVID-19 pneumonia can be observed (imaging is optional and can be included or excluded).
  • Severe: Any one of the following in adults cannot be explained by causes other than COVID-19 infection:
  • dyspnea with RR ≥30 breaths/min.
  • SpO2≤93% at rest when inhaling air.
  • Ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤300 mmHg.
Show all 11Show fewer
  • Disease progression with significant increase in pulmonary lesions within 24-48 hours.
  • Critical: Any one of the following conditions:
  • respiratory failure requiring mechanical ventilation.
  • shock.
  • other organ dysfunction requiring ICU monitoring and treatment. (d) Positive nucleic acid or antigen test; (e) No prior treatment with umbilical cord mesenchymal stem cell-derived exosomes; (f) The patient has a full understanding of the purpose and requirements of this trial and is willing to complete all trial procedures according to the trial requirements.

Who cannot join

  • Female patients of childbearing age who are pregnant, lactating, or planning to conceive within the past year; (b) Severe heart, brain, kidney, hematopoietic system diseases, or other serious illnesses; (c) Neuro-muscular diseases causing impaired natural ventilation, including but not limited to spinal cord injury above the level of C5, amyotrophic lateral sclerosis, Guillain-Barre syndrome, and myasthenia gravis; (d) Currently undergoing hemodialysis or peritoneal dialysis; (e) Acute myocardial infarction within 30 days prior to screening; (f) Patients with lung or bone marrow transplantation; (g) History of epilepsy requiring continuous anticonvulsant treatment, or received anticonvulsant treatment within the past 3 years; (h) Active immunosuppression, defined as receiving immunosuppressive drugs or having medical conditions related to immunodeficiency. This includes:
  • HIV (AIDS or CD4<200 cells/mm3).
  • chemotherapy within 4 weeks before randomization.
  • long-term immunosuppressive therapy, including maintenance prednisone therapy (>40mg/day or equivalent for >1 month).
  • absolute neutrophil count <500/mm3. Exceptions are patients who have received short-term systemic (intravenous or oral) steroid treatment for <1 week or topical steroid treatment for skin disorders; (i) Patients with severe allergic reactions or contraindications to the treatment regimen in this study; (j) Patients with doubts about the treatment plan or obvious mental and psychological disorders; (k) Patients whom the investigator considers unsuitable for participation in this trial (such as factors that may reduce compliance with follow-up or refusal to accept relevant supportive treatment by the patient).

Trial locations and contacts

1 site in 1 country.

Dan Yao, Master contact

0577-55579271

zdyaodan@163.com

Xiaoying Huang, Docter contact

0577-55579272

zjwzhxy@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Dan Yao The First Affiliated Hospital of Wenzhou Medical University, Master, 0577-55579271, zdyaodan@163.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Study on the Safety and Efficacy of Mesenchymal Stem Cell Exosomes in the Treatment of Coronavirus Infection.

This clinical study aims to investigate the safety and efficacy of nebulized inhalation of extracellular vesicles derived from mesenchymal stem cells combined with standard therapy for COVID-19-infected individuals. The primary objective is to determine whether nebulized MSC-secreted extracellular vesicles may be a feasible approach to alleviate COVID-19-induced lung injuries and promote recovery. Participants will be allocated to receive either nebulized MSC-secreted extracellular vesicles twice a day (BID) for 5 days as the test group or nebulized saline solution twice a day for 5 days as the control group. Researchers will compare the test and control groups to evaluate the safety and efficacy of extracellular vesicles in combination with standard therapy.

Read the detailed description
  1. Background 1.1. New Coronavirus Infection and Current Medical Strategies The 2019 coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been raging for over three years, causing more than 5 million deaths worldwide. The World Health Organization has declared COVID-19 pneumonia a global pandemic and a public health emergency[1]. Although diagnostic efficiency and treatment accuracy have improved, the overall treatment effect is still limited. The main causes of death include severe pneumonia, acute respiratory distress syndrome (ARDS), pulmonary edema, or multiple organ failure[2]. Among them, ARDS is the most severe. Pathological studies have shown that the pathogenesis of ARDS is mainly due to the immune response induced by the coronavirus attacking alveolar cells; immune cell infiltration leads to destruction of the pulmonary capillary endothelial structure, causing plasma, plasma proteins, and blood cells to enter the lung interstitium and alveolar cavity, forming pulmonary edema. Due to the destruction of the alveolar epithelial tissue, a large amount of edema fluid enters the alveoli, resulting in limited diffusion function of the alveoli and inability to perform normal respiratory function. At the same time, with the aggravation of tissue damage, cells further release various inflammatory factors to form a so-called cytokine storm, which finally completely destroys most of the pulmonary alveoli and bronchial respiratory structures, causing severe ventilation-perfusion imbalance and ultimately death of the patient[3]. In this global emergency event of coronavirus, the main medical strategy to combat COVID-19 is to use antibiotics and antiviral drugs to block the virus replication cycle and suppress host inflammation. This strategy has led to effective supportive and symptomatic treatment in some cases, even yielding promising results, but it is not the ultimate treatment for this infection. For example, immune regulation interventions like tocilizumab (IL-6 receptor blocker), adalimumab (anti-TNF antibody), and eculizumab (anti-C5 antibody) can effectively relieve patient symptoms but cannot cure the disease fundamentally. In fact, there are two major characteristics of COVID-19 pneumonia: first, people with low immunity are more susceptible to COVID-19[4], and second, the main target organ is the lungs[5]. In fact, respiratory failure has been reported as one of the main causes of death from COVID-19[6], and autopsies have shown lung damage, significant exudative reactions, and pulmonary embolism in many patients[7]. 1.2. Mesenchymal Stem Cell Exosomes Mesenchymal stem cells (MSCs) have been shown to have comprehensive and powerful immunomodulatory and regenerative functions[8]. MSCs can combat cell death associated with the pathogenesis of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, asthma, ARDS, and pulmonary hypertension, and promote cell regeneration[9,10]. Exosomes are one of the key paracrine effectors secreted by MSCs and are considered attractive candidates for alternative MSC therapy due to their biocompatibility similar to parent cells and their ability to maintain healing properties[11]. Under physiological and pathological conditions, exosomes play a key role in intercellular communication by transporting various biomolecules such as miRNA and proteins to target cells[12]. Unlike apoptotic bodies and microvesicles derived from the cell surface, exosomes are produced through the endocytic pathway and load cytoplasmic content of the parent cell. Therefore, they are mini versions of parent cells, mimicking some of their physiological characteristics. Compared to cell counterparts, the non-toxicity, low immunogenicity, high stability, ease of storage, and potential for mass production as ready-made products are several advantages of exosomes, which have led to their expansion in clinical applications as new therapeutic alternatives. In addition, the natural function of exosomes allows them to deliver their membrane and cytoplasmic bioactive components from parent cells to target cells through membrane fusion[13]. There are also other unique characteristics, including the natural ability to cross biological barriers such as the blood-brain barrier (BBB). Furthermore, biocompatibility is another characteristic. Due to their origin from biological sources and inherent targeting ability, exosomes have been used as carriers of drug components in preclinical studies[14]. 1.3. Mechanism of Mesenchymal Stem Cell-derived Exosomes Treatment MSC-derived exosomes inherit immune suppressive properties from their parent cells, and MSC-evs may use various mechanisms to balance the immune system's function. One key mechanism is reprogramming and altering the phenotype of various immune cells. For example, the ability of MSC-derived exosomes to promote the survival of alveolar macrophages and shift their phenotype from pro-inflammatory (M1) polarization to anti-inflammatory (M2) polarization has been demonstrated in at least two studies. These findings suggest that exosomes can serve as viable alternatives to their parent cells, and this ability has also been reported to alter the Treg/Teff ratio to increase Treg and promote the secretion of anti-inflammatory cytokines[15,16]. In multiple models, MSC-evs have similar therapeutic characteristics to MSCs, are easier to prepare, store and transport to the bedside, and avoid some limitations of cell therapy, such as the risk of pulmonary embolism and tumor formation. In recent years, MSC-evs have received widespread attention as biomarkers of pathogenesis and therapeutic drugs for a variety of diseases. In addition, MSC-secreted exosomes can regulate immunity through interaction with immune cells and inhibit inflammatory responses through cytokines[17,18]. Numerous studies have shown that MSC-secreted exosomes can be used to treat immune deficiencies, inflammation, ARDS, and other pulmonary diseases[19,20], so MSC-secreted exosomes may also be effective in treating the lung inflammation caused by COVID-19.Exosomes are one of the main active ingredients secreted by stem cells and are 30-150 nm in size. After nebulization, exosomes can directly reach the bronchioles and alveoli, which is conducive to the maximum absorption of drugs[21]. Multiple clinical trials have shown that intravenous infusion of MSCs and MSC-evs for the treatment of severe lung damage caused by SARS-CoV-2 is safe and effective[22], and in the case of lung injury, the nebulization route provides a particularly effective drug delivery method to target lung sites. Therefore, we speculate that nebulized MSC-secreted exosomes may be an effective method for reducing COVID-19 lung damage and promoting recovery. 1.4. Clinical Case Studies of Stem Cell-derived Exosomes Recently, the inhaled anti-COVID-19 drug Exo-CD24, led by Israeli medical center expert Nadir Arber, which is a combination of exosomes and CD24 protein, has shown promising results in early clinical trials. The drug was able to cure 29 out of 30 severe patients within 5 days of treatment and has the potential to treat COVID-19 patients within 3-5 days. Although Exo-CD24 has not yet passed phase III testing, it has shown great potential in the future[23]. The US FDA has approved the use of extracellular vesicles (EVS) for the treatment of COVID-19 through a Phase I/II trial conducted by Direct Biologics. ExoFlo, the EVS used, restores the health and vitality of patients by reducing sustained inflammation, promoting the revascularization of damaged tissue, and reshaping scar tissue. Domestic clinical studies have also been initiated, clinical research at the Fifth People's Hospital of Wuxi City, Jiangsu Province has confirmed that nebulized umbilical cord mesenchymal stem cell-derived extracellular vesicles are a safe and viable treatment for COVID-19. The study was published in Stem Cell Reviews and Reports in June of this year and included seven patients diagnosed with COVID-19 pneumonia, including two severe cases (Patients 2 and 4) and five mild cases (Patients 1, 3, 5, 6, and 7). No acute allergic reactions such as throat or tongue swelling, rash, shortness of breath, dizziness, vomiting, or hypotension were observed in any of the patients within two hours after nebulization treatment. There were also no reported adverse events or secondary allergic reactions following treatment. Chest CT scans showed a decrease in lung lobe nodule density and absorption of lung lesions in both severe and mild patients after nebulized treatment with MSC-derived extracellular vesicles[21]. Joint research by Ruijin Hospital and Jinyintan Hospital is being conducted on nebulized COVID-19 treatment using adipose-derived human allogeneic mesenchymal stem cell-derived exosomes (HAMSCs-Exos). Seven critically ill COVID-19 patients were treated with HAMSC-Exos via nebulization inhalation, and all patients tolerated the treatment well without evidence of adverse events or clinical instability during or immediately after nebulization. All patients showed an increase in serum lymphocyte count (median of 1.61×10^9/L vs 1.78×10^9/L), and lung lesions were reduced to varying degrees in all patients after inhaling HAMSC-Exos aerosols, with four patients showing significant improvement. Preliminary results suggest that participants' lung injuries were significantly improved[21]. However, most clinical trials using stem cell exosomes for COVID-19 infection have the following issues: (a) small sample size, making it difficult to effectively demonstrate the advantages of stem cell exosomes in COVID-19 treatment; (b) lack of a control group; (c) use of traditional two-dimensional production methods, making it difficult to scale up production of large quantities of exosomes for clinical treatment; and (d) lack of in-depth mechanism exploration for relevant phenomena. These problems hinder progress in the use of stem cell exosomes for COVID-19 infection treatment. To address these issues, this project proposes combining nebulized umbilical cord mesenchymal stem cell exosomes with conventional treatment to treat middle to severe COVID-19 patients and evaluate its safety and efficacy.
  2. Research Objective This study aims to evaluate the safety and effectiveness of umbilical cord mesenchymal stem cell-derived exosomes (nebulized) combined with conventional therapy for the treatment of moderate, severe, and critically ill COVID-19 patients through a multicenter, randomized controlled, single-blind clinical trial.
  3. Research Design This study adopts a multicenter, randomized controlled, single-blind trial design. Based on the COVID-19 treatment regimen formulated by clinical guidelines, nebulized umbilical cord mesenchymal stem cell-derived exosomes (experimental group) or medically sterile saline solution (control group) will be administered to treat moderate, severe, and critically ill COVID-19 patients. By comparing the relief of symptoms and the occurrence of adverse events before and after treatment, the safety and effectiveness of umbilical cord mesenchymal stem cell-derived exosomes for the treatment of moderate, severe, and critically ill COVID-19 patients will be evaluated.
Being tested
Extracellular Vesicles from Mesenchymal Stem Cells
Keywords
COVID-19, Exosomes, Mesenchymal Stem Cell
Medical subject headings
COVID-19

What participants receive

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

  • Extracellular Vesicles from Mesenchymal Stem CellsBiological

    Umbilical cord mesenchymal stem cell-derived extracellular vesicle preparation; Specification: 5ml, with extracellular vesicle concentration of 1 × 109 particles/ml in the preparation;

Study groups in NCT05787288
Study groupRoleWhat they receive
Test GroupExperimentalNebulized Mesenchymal Stem Cell Exosomes-derived extracellular vesicles twice a day (BID) for 5 days
Receives: Biological: Extracellular Vesicles from Mesenchymal Stem Cells
Control GroupSham comparatorNebulized saline solution twice a day (BID) for 5 days
Receives: Biological: Extracellular Vesicles from Mesenchymal Stem Cells

What is being measured

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

  1. Symptom remission time after atomizing medication;

    Symptom remission time after atomizing medication;

    Measured: 3 months

  2. Improvement of serum inflammatory markers;

    Improvement of serum inflammatory markers;

    Measured: 3 months

  3. If there is baseline CT, CT review and comparison;

    If there is baseline CT, CT review and comparison;

    Measured: 3 months

Secondary outcomes (2)

  1. Length of be hospitalized;

    Length of be hospitalized;

    Measured: 3 months

  2. Recovery time (nucleic acid turned negative)

    Recovery time (nucleic acid turned negative)

    Measured: 3 months

Timeline

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

  1. First posted28 Mar 2023
  2. Study start23 Jan 2023
  3. Primary completion23 Jan 2024 (estimated)
  4. Study completion23 Jan 2025 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05787288
Sponsor's protocol ID
KY2022-205
Status last verified
Apr 2023
First submitted
27 Mar 2023
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • El-Shennawy L, Hoffmann AD, Dashzeveg NK, McAndrews KM, Mehl PJ, Cornish D, Yu Z, Tokars VL, Nicolaescu V, Tomatsidou A, Mao C, Felicelli CJ, Tsai CF, Ostiguin C, Jia Y, Li L, Furlong K, Wysocki J, Luo X, Ruivo CF, Batlle D, Hope TJ, Shen Y, Chae YK, Zhang H, LeBleu VS, Shi T, Swaminathan S, Luo Y, Missiakas D, Randall GC, Demonbreun AR, Ison MG, Kalluri R, Fang D, Liu H. Circulating ACE2-expressing extracellular vesicles block broad strains of SARS-CoV-2. Nat Commun. 2022 Jan 20;13(1):405. doi: 10.1038/s41467-021-27893-2.

    PubMed 35058437

  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PubMed 31986264

  • Yildirim F, Karaman I, Kaya A. Current situation in ARDS in the light of recent studies: Classification, epidemiology and pharmacotherapeutics. Tuberk Toraks. 2021 Dec;69(4):535-546. doi: 10.5578/tt.20219611.

    PubMed 34957747

  • Banerjee A, Pasea L, Harris S, Gonzalez-Izquierdo A, Torralbo A, Shallcross L, Noursadeghi M, Pillay D, Sebire N, Holmes C, Pagel C, Wong WK, Langenberg C, Williams B, Denaxas S, Hemingway H. Estimating excess 1-year mortality associated with the COVID-19 pandemic according to underlying conditions and age: a population-based cohort study. Lancet. 2020 May 30;395(10238):1715-1725. doi: 10.1016/S0140-6736(20)30854-0. Epub 2020 May 12.

    PubMed 32405103

  • Rubin R. Global Effort to Collect Data on Ventilated Patients With COVID-19. JAMA. 2020 Jun 9;323(22):2233-2234. doi: 10.1001/jama.2020.8341. No abstract available.

    PubMed 32401275

  • Liang W, Liang H, Ou L, Chen B, Chen A, Li C, Li Y, Guan W, Sang L, Lu J, Xu Y, Chen G, Guo H, Guo J, Chen Z, Zhao Y, Li S, Zhang N, Zhong N, He J; China Medical Treatment Expert Group for COVID-19. Development and Validation of a Clinical Risk Score to Predict the Occurrence of Critical Illness in Hospitalized Patients With COVID-19. JAMA Intern Med. 2020 Aug 1;180(8):1081-1089. doi: 10.1001/jamainternmed.2020.2033.

    PubMed 32396163

  • Wichmann D, Sperhake JP, Lutgehetmann M, Steurer S, Edler C, Heinemann A, Heinrich F, Mushumba H, Kniep I, Schroder AS, Burdelski C, de Heer G, Nierhaus A, Frings D, Pfefferle S, Becker H, Bredereke-Wiedling H, de Weerth A, Paschen HR, Sheikhzadeh-Eggers S, Stang A, Schmiedel S, Bokemeyer C, Addo MM, Aepfelbacher M, Puschel K, Kluge S. Autopsy Findings and Venous Thromboembolism in Patients With COVID-19: A Prospective Cohort Study. Ann Intern Med. 2020 Aug 18;173(4):268-277. doi: 10.7326/M20-2003. Epub 2020 May 6.

    PubMed 32374815

  • Carrade Holt DD, Wood JA, Granick JL, Walker NJ, Clark KC, Borjesson DL. Equine mesenchymal stem cells inhibit T cell proliferation through different mechanisms depending on tissue source. Stem Cells Dev. 2014 Jun 1;23(11):1258-65. doi: 10.1089/scd.2013.0537. Epub 2014 Mar 4.

    PubMed 24438346

  • Sauler M, Bazan IS, Lee PJ. Cell Death in the Lung: The Apoptosis-Necroptosis Axis. Annu Rev Physiol. 2019 Feb 10;81:375-402. doi: 10.1146/annurev-physiol-020518-114320. Epub 2018 Nov 28.

    PubMed 30485762

  • Naji A, Suganuma N, Espagnolle N, Yagyu KI, Baba N, Sensebe L, Deschaseaux F. Rationale for Determining the Functional Potency of Mesenchymal Stem Cells in Preventing Regulated Cell Death for Therapeutic Use. Stem Cells Transl Med. 2017 Mar;6(3):713-719. doi: 10.5966/sctm.2016-0289. Epub 2016 Oct 11.

    PubMed 28297565

  • Janockova J, Slovinska L, Harvanova D, Spakova T, Rosocha J. New therapeutic approaches of mesenchymal stem cells-derived exosomes. J Biomed Sci. 2021 May 25;28(1):39. doi: 10.1186/s12929-021-00736-4.

    PubMed 34030679

  • Yao J, Huang K, Zhu D, Chen T, Jiang Y, Zhang J, Mi L, Xuan H, Hu S, Li J, Zhou Y, Cheng K. A Minimally Invasive Exosome Spray Repairs Heart after Myocardial Infarction. ACS Nano. 2021 Jul 27;15(7):11099-11111. doi: 10.1021/acsnano.1c00628. Epub 2021 Jun 21.

    PubMed 34152126

  • Noori L, Arabzadeh S, Mohamadi Y, Mojaverrostami S, Mokhtari T, Akbari M, Hassanzadeh G. Intrathecal administration of the extracellular vesicles derived from human Wharton's jelly stem cells inhibit inflammation and attenuate the activity of inflammasome complexes after spinal cord injury in rats. Neurosci Res. 2021 Sep;170:87-98. doi: 10.1016/j.neures.2020.07.011. Epub 2020 Jul 25.

    PubMed 32717259

  • Park J, Kim S, Lim H, Liu A, Hu S, Lee J, Zhuo H, Hao Q, Matthay MA, Lee JW. Therapeutic effects of human mesenchymal stem cell microvesicles in an ex vivo perfused human lung injured with severe E. coli pneumonia. Thorax. 2019 Jan;74(1):43-50. doi: 10.1136/thoraxjnl-2018-211576. Epub 2018 Aug 3.

    PubMed 30076187

  • Zhang Y, Chen J, Fu H, Kuang S, He F, Zhang M, Shen Z, Qin W, Lin Z, Huang S. Exosomes derived from 3D-cultured MSCs improve therapeutic effects in periodontitis and experimental colitis and restore the Th17 cell/Treg balance in inflamed periodontium. Int J Oral Sci. 2021 Dec 14;13(1):43. doi: 10.1038/s41368-021-00150-4.

    PubMed 34907166

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Extracellular Vesicles from Mesenchymal Stem Cells in people with COVID-19 Pneumonia, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

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 11 inclusion and 5 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 7 Apr 2023. 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 China. 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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Dan Yao, Master (0577-55579271, zdyaodan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom remission time after atomizing medication; (time frame: 3 months). The study lists 3 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 NCT05787288, which also lists 22 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 7 Apr 2023.

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