Studies
| Study First Submitted Date | 2021-08-18 |
| Study First Posted Date | 2021-08-23 |
| Last Update Posted Date | 2023-04-18 |
| Start Month Year | November 1, 2023 |
| Primary Completion Month Year | November 1, 2024 |
| Verification Month Year | April 2023 |
| Verification Date | 2023-04-30 |
| Last Update Posted Date | 2023-04-18 |
Conditions
| Sequence: | 52435045 | Sequence: | 52435046 |
| Name | Corona Virus Infection | Name | Covid19 |
| Downcase Name | corona virus infection | Downcase Name | covid19 |
Id Information
| Sequence: | 40346402 |
| Id Source | org_study_id |
| Id Value | CTX0020-004 |
Design Groups
| Sequence: | 55885770 | Sequence: | 55885771 |
| Group Type | Experimental | Group Type | Placebo Comparator |
| Title | Study Group | Title | Control Group |
| Description | Each subject receives three separate doses of 200 million allogeneic adipose-derived mesenchymal stem cells via intravenously infusion on days 0, 3, and 6 with a total of 600 million AdMSCs during 7 days in addition to their standard of care. | Description | The control group will receive placebo infusion on day 0, 3 and 6 along with standard of care. |
Interventions
| Sequence: | 52744364 |
| Intervention Type | Biological |
| Name | Allogeneic adipose-derived stem cells |
| Description | Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue |
Design Outcomes
| Sequence: | 178370949 | Sequence: | 178370950 | Sequence: | 178370951 | Sequence: | 178370952 | Sequence: | 178370953 | Sequence: | 178370954 | Sequence: | 178370955 | Sequence: | 178370956 | Sequence: | 178370957 | Sequence: | 178370958 | Sequence: | 178370959 | Sequence: | 178370960 | Sequence: | 178370961 | Sequence: | 178370962 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other |
| Measure | Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects. | Measure | Safety for AdMSCs based upon incidence of all AEs | Measure | Compare the mortality rate | Measure | Recognized immune measurements evaluating patients' symptom changes and overall function | Measure | Organ functional tests including blood specific enzymes and proteins | Measure | Duration (days) of weaning from mechanical ventilation | Measure | Duration (days) of ICU monitoring | Measure | Duration (days) of vasoactive agent's usage | Measure | Duration of hospitalization (days) | Measure | Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method | Measure | Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method | Measure | Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive | Measure | Mortality rate down to 0% | Measure | Achieve at least 30% more proportion of severe patients in AdMSC study group without developing organ failure or recovery from previous organ failure |
| Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months |
| Description | Incidence of treatment-related adverse events and severe adverse events during the study period | Description | Grouped by Medical Dictionary for Regulatory Activities (MedDRA) | Description | AdMSC treating group vs. control group | Description | To evaluate change of sequential organ failure assessment (SOFA) score as compare to the baseline | Description | To evaluate the efficacy of allogeneic AdMSCs for COVID-19 | Description | Compared to control group | Description | Compared to control group | Description | Compared to control group | Description | Compared to control group | Description | Compared to control group | Description | Compared to control group | Description | Compared to control group | Description | For severe and critical cases | Description | Compared to control group |
Browse Conditions
| Sequence: | 194490169 | Sequence: | 194490170 | Sequence: | 194490171 | Sequence: | 194490172 | Sequence: | 194490173 | Sequence: | 194490174 | Sequence: | 194490175 | Sequence: | 194490176 | Sequence: | 194490177 | Sequence: | 194490178 | Sequence: | 194490179 | Sequence: | 194490180 |
| Mesh Term | COVID-19 | Mesh Term | Coronavirus Infections | Mesh Term | Pneumonia, Viral | Mesh Term | Pneumonia | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Virus Diseases | Mesh Term | Coronaviridae Infections | Mesh Term | Nidovirales Infections | Mesh Term | RNA Virus Infections | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
| Downcase Mesh Term | covid-19 | Downcase Mesh Term | coronavirus infections | Downcase Mesh Term | pneumonia, viral | Downcase Mesh Term | pneumonia | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | coronaviridae infections | Downcase Mesh Term | nidovirales infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48563453 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Celltex Therapeutics Corporation |
Overall Officials
| Sequence: | 29422405 |
| Role | Principal Investigator |
| Name | Derek W Guillory, MD |
| Affiliation | Root Causes Medicine |
Central Contacts
| Sequence: | 12078001 |
| Contact Type | primary |
| Name | Jane Young, Ph.D. |
| Phone | 7135901000 |
| jyoung@celltexbank.com | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68509964 | Sequence: | 68509965 |
| Design Group Id | 55885771 | Design Group Id | 55885770 |
| Intervention Id | 52744364 | Intervention Id | 52744364 |
Eligibilities
| Sequence: | 30916469 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Age above 18 years. Male and female Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive Clinical diagnosis meets severe and/or critical parameters Male participants must be willing to ensure their partners do not become pregnant either by practicing abstinence or the use of condoms during sexual activity Exclusion Criteria: Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start Unwillingness or inability to comply with study procedures Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc. Clinically active malignant disease Subjects who are receiving ECMO and CRRT currently History of known pulmonary embolism or known secondary anti-phospholipid syndrome Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO) Known or suspected allergic to diphenhydramine. Major trauma or surgery within 14 days of study treatment start Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study Alcohol, drug, or medication abuse within one year prior to study treatment start Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study Irreversible severe end organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions Patients or family history with hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc. History of long-term use of immunosuppressive agents Organ transplants in the past 6 months Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study. Patients with previous pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia before COVID-19 infection. The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed. QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test. Subjects are not medically unstable at time of infusion including but not limiting unstable hypertension, pulse, oximetry, etc. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254182221 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 3 |
| Number Of Secondary Outcomes To Measure | 9 |
| Number Of Other Outcomes To Measure | 2 |
Designs
| Sequence: | 30662154 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Quadruple |
| Intervention Model Description | The Phase 2 study is a randomized, double blind and placebo control study conducted initially in a single clinic facility. |
| Subject Masked | True |
| Caregiver Masked | True |
| Investigator Masked | True |
| Outcomes Assessor Masked | True |
Intervention Other Names
| Sequence: | 26804117 |
| Intervention Id | 52744364 |
| Name | Celltex-AdMSCs |
Responsible Parties
| Sequence: | 29028838 |
| Responsible Party Type | Sponsor |