Ignite Creation Date:
2024-07-17 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492798
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-21
Brief Title:
Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the effectiveness and safety of mesenchymal stem cell therapy in long-COVID patients The main questions it aims to answer include
whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients
whether umbilical cord mesenchymal stem cell therapy is safe for long-COVID patients
Participants demographics chief complaints and vital signs will be collected and recorded Basic physical examinations bloodwork routine biochemical indexes oxygen saturation SpO2 levels 6-minute walk tests high-resolution computed tomography HRCT scan if necessary results will be conducted
Participants will receive either an intravenous infusion of mesenchymal stem cells or a placebo for one time Participants symptoms will be assessed on Day 28 of the trial If there is no significant effect an additional infusion will be given on Days 35-42 and the symptoms will be reassessed 28 days after that
Continuous nebulized inhalation of UCMSC-derived exosomes will be administered for 5 days twice daily to treatment group with no treatment given to the control group Researchers will compare data and information collected from the treatment and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection
whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients
whether umbilical cord mesenchymal stem cell therapy is safe for long-COVID patients
Participants demographics chief complaints and vital signs will be collected and recorded Basic physical examinations bloodwork routine biochemical indexes oxygen saturation SpO2 levels 6-minute walk tests high-resolution computed tomography HRCT scan if necessary results will be conducted
Participants will receive either an intravenous infusion of mesenchymal stem cells or a placebo for one time Participants symptoms will be assessed on Day 28 of the trial If there is no significant effect an additional infusion will be given on Days 35-42 and the symptoms will be reassessed 28 days after that
Continuous nebulized inhalation of UCMSC-derived exosomes will be administered for 5 days twice daily to treatment group with no treatment given to the control group Researchers will compare data and information collected from the treatment and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection
Detailed Description:
Since the outbreak of the COVID-19 pandemic according to the official statistics from the WHO website there have been over 694 million confirmed cases worldwide until August 2023 with approximately 69 million deaths In addition to the high incidence and mortality rates in the initial weeks following infection up to 70 of COVID-19 patients may experience long-term complications significantly impacting human health and placing a substantial burden on hospital resources
A study evaluated 2320 adult participants who were discharged between March 7 2020 and April 18 2021 from several National Health Service NHS hospitals in the United Kingdom and found that only 255 of COVID-19 patients had fully recovered five months after discharge And the improvement in patients conditions was minimal even when study period was extended to one year 71 of patients continued to experience one or more post-COVID-19 sequelae with common symptoms including fatigue difficulty breathing muscle pain and insomnia etc According to multiple studies post-COVID-19 sequelae may involve 203 different symptoms and affect 10 organ systems in the body including the neurological reproductive cardiovascular and pulmonary systems The World Health Organization WHO published an official definition of long COVID in October 2021 They define it as a condition that occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis Despite some guidelines for the management of long COVID there is still a lack of specific treatment methods Currently the most important strategy is vaccination Vaccination can help alleviate symptoms during the acute infection period and studies have found that individuals who are vaccinated against COVID-19 have approximately a 50 lower risk of developing long COVID compared to those who are unvaccinated Also there are other therapies that are in the clinical research stage and one of which is stem cell therapy Mesenchymal stem cells MSCs are a type of cell with self-renewal and multi-directional differentiation abilities They are the primitive seed cells that form various tissues and organs in the human body Under specific conditions MSCs can differentiate into various cells in the human body including osteoblasts adipocytes chondrocytes and other cells of the stromal lineage and repair tissue damage through the secretion of corresponding factors Meanwhile MSCs also act as inflammation terminators by regulating immune reactions through paracrine functions and interactions with immune cells This ultimately leads to the downregulation of local inflammatory responses and alleviation of excessive immune reactions
The research team led by Wang Fusheng published a study in the journal eBioMedicine impact factor 8143 in 2022 which explored the use of umbilical cord mesenchymal stem cells UC-MSCs for the treatment of severe COVID-19 patients and followed up patients for one year The study confirmed that UC-MSCs therapy as an adjuvant therapy has long-term benefits for lung injury in severe COVID-19 patients This was a randomized double-blind controlled trial with 100 patients randomly assigned in a 21 ratio 65 in the UC-MSCs group and 35 in the control group The results showed that UC-MSCs helped in the resolution of lung consolidative lesions with 179 of patients in the UC-MSCs group having normal CT images after one year of follow-up In contrast the control placebo group had not recovered from lung injury There were no significant differences in the incidence of adverse events between the two groups And in Japan the Japanese Respiratory Syndrome Society has been conducting research on the long-term effects of COVID-19 since August 1 2020 According to foreign media reports the Kyushu Regenerative Medicine Special Committee in Japan has approved a program for the use of autologous adipose-derived mesenchymal stem cells in the treatment of post-COVID-19 syndrome This patented technology developed by the Korean Stem Cell Research Institute has undergone a 120-day review and three rounds of screening by a committee of 16 experts from various fields and has passed the review of the current regenerative medical plan for post-COVID-19 syndrome The director of the Stem Cell Research Institute who developed this therapy stated This approval has received strong support from the Regenerative Medicine Special Committee The investigators believe that mesenchymal stem cells through their anti-inflammatory and tissue regeneration effects will have good results in treating post-COVID-19 syndrome This study aims to evaluate the effectiveness and safety of mesenchymal cell therapy for long COVID-19 patients It is a prospective exploratory study randomized double-blind placebo-controlled trial planning to include a total of 76 patients who have been infected with COVID-19 By assessing the improvement of CTCAE 50 symptom scores in the treatment group and control group at 28 days 12 weeks and 24 weeks after treatment completion the effectiveness and safety of mesenchymal stem cells in patients with long- term COVID-19 will be evaluated This study is divided into two stages Stage one 10 patients will be enrolled all receiving mesenchymal stem cell treatment primarily assessing their safety Stage two 66 patients will be enrolled randomly assigned in a 11 ratio to the treatment group and control group evaluating the effectiveness and safety of mesenchymal stem cell therapy for long-term COVID-19
A study evaluated 2320 adult participants who were discharged between March 7 2020 and April 18 2021 from several National Health Service NHS hospitals in the United Kingdom and found that only 255 of COVID-19 patients had fully recovered five months after discharge And the improvement in patients conditions was minimal even when study period was extended to one year 71 of patients continued to experience one or more post-COVID-19 sequelae with common symptoms including fatigue difficulty breathing muscle pain and insomnia etc According to multiple studies post-COVID-19 sequelae may involve 203 different symptoms and affect 10 organ systems in the body including the neurological reproductive cardiovascular and pulmonary systems The World Health Organization WHO published an official definition of long COVID in October 2021 They define it as a condition that occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis Despite some guidelines for the management of long COVID there is still a lack of specific treatment methods Currently the most important strategy is vaccination Vaccination can help alleviate symptoms during the acute infection period and studies have found that individuals who are vaccinated against COVID-19 have approximately a 50 lower risk of developing long COVID compared to those who are unvaccinated Also there are other therapies that are in the clinical research stage and one of which is stem cell therapy Mesenchymal stem cells MSCs are a type of cell with self-renewal and multi-directional differentiation abilities They are the primitive seed cells that form various tissues and organs in the human body Under specific conditions MSCs can differentiate into various cells in the human body including osteoblasts adipocytes chondrocytes and other cells of the stromal lineage and repair tissue damage through the secretion of corresponding factors Meanwhile MSCs also act as inflammation terminators by regulating immune reactions through paracrine functions and interactions with immune cells This ultimately leads to the downregulation of local inflammatory responses and alleviation of excessive immune reactions
The research team led by Wang Fusheng published a study in the journal eBioMedicine impact factor 8143 in 2022 which explored the use of umbilical cord mesenchymal stem cells UC-MSCs for the treatment of severe COVID-19 patients and followed up patients for one year The study confirmed that UC-MSCs therapy as an adjuvant therapy has long-term benefits for lung injury in severe COVID-19 patients This was a randomized double-blind controlled trial with 100 patients randomly assigned in a 21 ratio 65 in the UC-MSCs group and 35 in the control group The results showed that UC-MSCs helped in the resolution of lung consolidative lesions with 179 of patients in the UC-MSCs group having normal CT images after one year of follow-up In contrast the control placebo group had not recovered from lung injury There were no significant differences in the incidence of adverse events between the two groups And in Japan the Japanese Respiratory Syndrome Society has been conducting research on the long-term effects of COVID-19 since August 1 2020 According to foreign media reports the Kyushu Regenerative Medicine Special Committee in Japan has approved a program for the use of autologous adipose-derived mesenchymal stem cells in the treatment of post-COVID-19 syndrome This patented technology developed by the Korean Stem Cell Research Institute has undergone a 120-day review and three rounds of screening by a committee of 16 experts from various fields and has passed the review of the current regenerative medical plan for post-COVID-19 syndrome The director of the Stem Cell Research Institute who developed this therapy stated This approval has received strong support from the Regenerative Medicine Special Committee The investigators believe that mesenchymal stem cells through their anti-inflammatory and tissue regeneration effects will have good results in treating post-COVID-19 syndrome This study aims to evaluate the effectiveness and safety of mesenchymal cell therapy for long COVID-19 patients It is a prospective exploratory study randomized double-blind placebo-controlled trial planning to include a total of 76 patients who have been infected with COVID-19 By assessing the improvement of CTCAE 50 symptom scores in the treatment group and control group at 28 days 12 weeks and 24 weeks after treatment completion the effectiveness and safety of mesenchymal stem cells in patients with long- term COVID-19 will be evaluated This study is divided into two stages Stage one 10 patients will be enrolled all receiving mesenchymal stem cell treatment primarily assessing their safety Stage two 66 patients will be enrolled randomly assigned in a 11 ratio to the treatment group and control group evaluating the effectiveness and safety of mesenchymal stem cell therapy for long-term COVID-19
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None