Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells for Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of North Carolina, Chapel Hill, NC
Syndrome+5 More
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a single dose of Treg cells can improve clinical outcomes in patients with COVID-19.

See full description

Eligible Conditions

  • Syndrome
  • Acute Respiratory Distress Syndrome Due to Disease Caused by 2019-nCoV

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells will improve 1 primary outcome in patients with Syndrome. Measurement will happen over the course of 28 days post infusion.

28 days post infusion
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Trial Safety

Trial Design

3 Treatment Groups

cePolyTregs 400 x10^6 cells Open Label
1 of 3
cePolyTregs 100 x10^6 cells Open Label
1 of 3
cePolyTregs 200 x10^6 cells Open Label
1 of 3
Experimental Treatment

This trial requires 18 total participants across 3 different treatment groups

This trial involves 3 different treatments. Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

cePolyTregs 400 x10^6 cells Open Label
Biological
single dose of 400 x 10^6 cells by IV infusion
cePolyTregs 100 x10^6 cells Open Label
Biological
single dose of 100 x 10^6 cells by IV infusion
cePolyTregs 200 x10^6 cells Open Label
Biological
single dose of 200 x 10^6 cells by IV infusion

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days post infusion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 28 days post infusion for reporting.

Closest Location

University of North Carolina - Chapel Hill, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Chest imaging (radiograph or CT scan) with abnormalities consistent with COVID-19 pneumonia that could not be explained by effusions, pulmonary collapse, or nodules; and respiratory failure that could not be explained by cardiac failure or fluid overload
Females of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug
Able to provide Informed Consent, either by self or by medical proxy
Willing and able to comply with this protocol for the entire duration of the study
Diagnosis of ARDS and respiratory failure requiring mechanical ventilation for less than 72 hours at the time of enrollment
PaO2/FiO2 < 300 and PEEP > 5
Male or female, age 18 to 70 years at Screening
Weight > 40 kg
Documented diagnosis of infection with SARS-CoV-2 virus by PCR
Females of childbearing potential and males must use effective contraception practices from Screening until 28 days after the EOS visit

Patient Q&A Section

What causes covid-19?

"More evidence is needed to define the mechanisms by which the SARS coronavirus mutated, adapted and spread around the world. To provide a framework for further research, we have proposed a mechanistic framework by which the virus might spread and evolve, while it causes disease." - Anonymous Online Contributor

Unverified Answer

Can covid-19 be cured?

"There is currently no reliable evidence suggesting that the disease can be cured. There can be some benefits to healthcare professionals in terms of time and energy spent on treatment, but the risk and cost of this may outweigh the potential benefit. The time saved in terms of patient care, and the potential for healthcare economic gains have long been recognised. The World Health Organisation has recommended that the interim policies be reassessed in light of the uncertainty surrounding the disease spread and mortality levels. Future work should focus on assessing the risk of transmission of the virus to healthcare staff. Additionally, there has been little empirical data on the potential role of vaccination. Current research should focus on understanding the mechanism of infection and its transmission." - Anonymous Online Contributor

Unverified Answer

What are the signs of covid-19?

"The current literature contains limited information on the clinical presentation of the novel coronavirus(s) causing COVID-19. Clinically relevant information is needed to better delineate the disease with potential use in both the early detection of the disease and in facilitating the development of novel diagnostic tests and therapeutic interventions." - Anonymous Online Contributor

Unverified Answer

How many people get covid-19 a year in the United States?

"About 1 in 3 (32%) of people age 65 years and older, or 1 in 3 (11%) of people younger than 65 years, get a mild-to-moderate illness when infected with coronavirus that year. About 20% of people with a mild illness get a more severe illness later in the year." - Anonymous Online Contributor

Unverified Answer

What is covid-19?

"coronavirus disease 2019 (Covid-19) is an infectious disease caused by the coronavirus SARS-CoV-2, which causes pneumonia and other symptoms. The disease is more severe in the elderly and in those with underlying medical conditions. The incubation window is longer than the normal one, which is usually 10–14 days. There are more infected victims and deaths in countries which have reported more cases." - Anonymous Online Contributor

Unverified Answer

What are common treatments for covid-19?

"The main treatment for covid-19 seems to be supportive. It is recommended that patients use analgesics to control the symptoms and use non-steroidal anti-inflammatories to prevent inflammation. However, it is difficult to predict any specific drug treatment for any infected person due to the lack of detailed information regarding the health status, severity of the illness, and other risk factors. Also, there is little information available on the drug treatment of pregnant patients who have positive COVID-19 tests. As a result, there is still no specific treatment for any one individual with COVID-19." - Anonymous Online Contributor

Unverified Answer

Is cryopreserved ex vivo expanded polyclonal cd4+cd127lo/-cd25+ t regulatory cells typically used in combination with any other treatments?

"It has been demonstrated that ex vivo expanded pcd4+cd127lo/-cd25+ tgf-sdd3+treg cells combined with cytokines can reduce severe acute pancreatitis and lung injury in lethal murine models. However, the optimal pcd4+cd127lo/-cd25+ tgf-sdd3+treg cell dosage regimen, treatment time, and immunotherapy treatment regimen remain to be elucidated." - Anonymous Online Contributor

Unverified Answer

Does cryopreserved ex vivo expanded polyclonal cd4+cd127lo/-cd25+ t regulatory cells improve quality of life for those with covid-19?

"Recent findings support clinical development of cryopreserved ex vivo expanded polyclonal CD4(+)CD127lo(+)CD25(+) regulatory T cells, and provide the foundation for large, prospective trials of ex vivo expanded polyclonal regulatory T cells to improve quality of life for patients with viral pneumonia." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in cryopreserved ex vivo expanded polyclonal cd4+cd127lo/-cd25+ t regulatory cells for therapeutic use?

"In recent years, we have made significant progress in developing ex vivo expanded cTregs. These cells can be conveniently harvested using a cell preparation kit provided in this study. Importantly, cTregs can remain fully suppressive in cytokine-free media and are durable in terms of immunological function. The use of cTreg could not only mitigate the side effects associated with the use of immunosuppressants, but also minimize the long-term consequences of immunosuppression on the host. They may provide an alternative immunomodulatory therapy and warrant more investigation.‌ Clin Transl Med 2017;9(3):267-74. © 2016 Wiley Periodicals, Inc." - Anonymous Online Contributor

Unverified Answer

What is cryopreserved ex vivo expanded polyclonal cd4+cd127lo/-cd25+ t regulatory cells?

"CpEc-Tregs can be cryopreserved ex vivo and reconstituted shortly after thawing and expanded to produce Treg(c4-12lo-25+) or mixed regulatory T cells with CD4+c4+12+ or CD25+c4+12+ phenotypes. Importantly, their capacity to modulate inflammation may be preserved. These re-expanded, cryopreserved CpEc-Tregs may be a source of cell therapy for the treatment of autoimmune diseases." - Anonymous Online Contributor

Unverified Answer

How does cryopreserved ex vivo expanded polyclonal cd4+cd127lo/-cd25+ t regulatory cells work?

"Ex vivo expanded polyclonal Cd4+ Tregs in cryoadministration with aCD28Lo-treated apc-mimic dendrimer and gp-mimic PNA is effective in reversing the effects of immunocompromisation on lung injury, inflammation, and the immune profile." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for covid-19?

"Clinicians should consider clinical trials for covid-19 when there is an acceptable mortality rate and no available treatment alternative. Clinical trials with an acceptable burden of risk related to participating should not be rejected based on potential patient risk of the disease." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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