Organ Dysfunction Syndrome SepsisPhase 1P-SOFA-1NCT03925857
Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
A Phase 1 study testing Allocetra-OTS in people with Organ Dysfunction Syndrome Sepsis, run by Enlivex Therapeutics Ltd. at 1 site in Israel.
Trial summary
The trial evaluates the safety and efficacy of one and two doses of the study drug, Allocetra-OTS, in patients who have been diagnosed with sepsis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Organ Dysfunction Syndrome Sepsis
- What is being tested?
- Allocetra-OTS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Jan 2019to 12 Jan 2020
- Phase
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected, presumed or documented infection from any source.
- Initiation of antibiotics.
- Meets Sepsis 3 criteria: The presence of organ dysfunction as identified by a total SOFA score ≥ 2 points above baseline.
- Adult male or female, age between 18 and 85.
- GCS of >13 with verbal score of 5.
- Signed written informed consent by the patient.
Who cannot join
- Participation in an interventional investigational trial within 30 days prior to diagnosis of sepsis.
- Significant trauma requiring hospitalization within 30 days prior to diagnosis of sepsis.
- Surgical intervention or hospitalization within 45 days prior to diagnosis of sepsis.
- Pregnancy or breast-feeding female.
- Progressive or poorly-controlled malignancies or < 6 month after active treatment for cancer (chemotherapy or irradiation).
- Terminally ill patients defined as patients that prior to the current hospitalization are expected to live < 6 months (as assessed by the physician responsible for the patient).
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- Known active acute or chronic viral infections, e.g. Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) or other chronic infection.
- Known severe chronic respiratory health problems with severe pulmonary hypertension (≥40 mmHg) or respirator dependency.
- Known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to: biopsy-proven cirrhosis; portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.
- Known New York Heart Association (NYHA) class IV heart failure or unstable angina, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within six months prior to diagnosis of sepsis.
- Known immunocompromised state or medications known to be immunosuppressive.
- Organ allograft or previous history of stem cell transplantation
Trial locations and contacts
1 site in 1 country.
About this study
The trial evaluates the safety and efficacy of one and two doses of the study drug, Allocetra-OTS, in patients who have been diagnosed with sepsis.
Read the detailed description
The study drug, Allocetra-OTS is a cell-based therapeutic composed of donor apoptotic cells. The product contains allogeneic mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The study drug, Allocetra-OTS, is based on the known activity of apoptotic cells to contribute to maintenance of peripheral immune homeostasis. As altered immune response is associated with organ dysfunction in sepsis, the possibility is being tested that the study drug can improve the condition of sepsis.
- Conditions
- Organ Dysfunction Syndrome Sepsis
- Being tested
- Allocetra-OTS
- Keywords
- Allocetra-OTS, Cell based therapy, Apoptotic cells
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allocetra-OTSBiological
Allocetra-OTS contains allogeneic donor mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The suspension is prepared with Ringer's lactate solution.
| Study group | Role | What they receive |
|---|---|---|
| Allocetra-OTS | Experimental | Standard of Care (SOC) Drug: One dose Allocetra-OTS 140 140x106 /kg Receives: Biological: Allocetra-OTS |
| Allocetra-OTS Two doses | Experimental | Standard of Care (SOC) Drug: Two doses Allocetra-OTS 140 140x106 /kg Receives: Biological: Allocetra-OTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE
Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE
Measured: 28 days follow up
Secondary outcomes (5)
Organ function or support measurements
- Ventilator-free days, and/or
- Vasopressor-free days, and/or
- Days without renal replacement therapy (dialysis) and/or days with creatinine ≤ baseline +20%, and/or
- Days with ≥ 100x109/L platelets count, and/or
- Days with ≤ three times normal ALT (Alanine transaminase) and AST ••(Aspartate Aminotransferase) levels and/or ≤ two times normal bilirubin levels and/or
- Days with return to GCS (Glasgow Coma Scale) 15
Measured: 28 days follow up
Mortality
Incidence rate of Moratlity from any cause
Measured: 28 days follow up
Hospitalization
Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital.
Measured: 28 days follow up
CRP
Time to C-reactive protein (CRP) < 20 mg/L.
Measured: 28 days follow up
Lactate levels
Time to normal + 20% lactate levels
Measured: 28 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start27 Jan 2019
- Primary completion10 Dec 2019
- Study completion12 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Organ Dysfunction Syndrome SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- One Dose: 3 Sepsis patients will be treated with Allocetra-OTS, following safety assessment additional 3 patients will be treated (total 6 patients). Two doses: Once safety is established 4 sepsis patients will be treated with 2 doses of Allocetra-OTS; The first, as in the first six patients and the second 48 hr following the first treatment.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enlivex Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dror Mevorach, Prof, Study director, Enlivex Therapeutics LTD Email:mevorachd@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925857
- Sponsor's protocol ID
- ENX-CL-02-001
- Other IDs
- MOH_2019-02-17_005970
- Acronym
- P-SOFA-1
- Status last verified
- May 2020
- First submitted
- 1 Apr 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Heerden PV, Abutbul A, Sviri S, Zlotnick E, Nama A, Zimro S, El-Amore R, Shabat Y, Reicher B, Falah B, Mevorach D. Apoptotic Cells for Therapeutic Use in Cytokine Storm Associated With Sepsis- A Phase Ib Clinical Trial. Front Immunol. 2021 Sep 30;12:718191. doi: 10.3389/fimmu.2021.718191. eCollection 2021.
PubMed 34659208
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
- ClinicalTrials.gov ID
- NCT03925857
- Acronym / sponsor ID
- P-SOFA-1 / ENX-CL-02-001
- Conditions
- Organ Dysfunction Syndrome Sepsis
- Keywords
- Allocetra-OTS, Cell based therapy, Apoptotic cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Enlivex Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 12 Jan 2020 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial evaluates the safety and efficacy of one and two doses of the study drug, Allocetra-OTS, in patients who have been diagnosed with sepsis.
Detailed description
The study drug, Allocetra-OTS is a cell-based therapeutic composed of donor apoptotic cells. The product contains allogeneic mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The study drug, Allocetra-OTS, is based on the known activity of apoptotic cells to contribute to maintenance of peripheral immune homeostasis. As altered immune response is associated with organ dysfunction in sepsis, the possibility is being tested that the study drug can improve the condition of sepsis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One Dose: 3 Sepsis patients will be treated with Allocetra-OTS, following safety assessment additional 3 patients will be treated (total 6 patients). Two doses: Once safety is established 4 sepsis patients will be treated with 2 doses of Allocetra-OTS; The first, as in the first six patients and the second 48 hr following the first treatment.
| Arm | Type | Receives |
|---|---|---|
| Allocetra-OTS | Experimental | Biological: Allocetra-OTSStandard of Care (SOC) Drug: One dose Allocetra-OTS 140 140x106 /kg |
| Allocetra-OTS Two doses | Experimental | Biological: Allocetra-OTSStandard of Care (SOC) Drug: Two doses Allocetra-OTS 140 140x106 /kg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Suspected, presumed or documented infection from any source.
- Initiation of antibiotics.
- Meets Sepsis 3 criteria: The presence of organ dysfunction as identified by a total SOFA score ≥ 2 points above baseline.
- Adult male or female, age between 18 and 85.
- GCS of >13 with verbal score of 5.
Key exclusion criteria (12 listed)
- Participation in an interventional investigational trial within 30 days prior to diagnosis of sepsis.
- Significant trauma requiring hospitalization within 30 days prior to diagnosis of sepsis.
- Surgical intervention or hospitalization within 45 days prior to diagnosis of sepsis.
- Pregnancy or breast-feeding female.
- Progressive or poorly-controlled malignancies or < 6 month after active treatment for cancer (chemotherapy or irradiation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allocetra-OTSAllocetra-OTS contains allogeneic donor mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The suspension is prepared with Ringer's lactate solution. | Biological | Allocetra-OTS, Allocetra-OTS Two doses |
Primary outcome
Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE
Time frame: 28 days follow up
Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE
5 secondary outcomes
Organ function or support measurements
Time frame: 28 days follow up
Mortality
Time frame: 28 days follow up
Hospitalization
Time frame: 28 days follow up
CRP
Time frame: 28 days follow up
Lactate levels
Time frame: 28 days follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 34659208van Heerden PV, Abutbul A, Sviri S, Zlotnick E, Nama A, Zimro S, El-Amore R, Shabat Y, Reicher B, Falah B, Mevorach D. Apoptotic Cells for Therapeutic Use in Cytokine Storm Associated With Sepsis- A Phase Ib Clinical Trial. Front Immunol. 2021 Sep 30;12:718191. doi: 10.3389/fimmu.2021.718191. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror Mevorach, Prof study director
Enlivex Therapeutics LTD Email:mevorachd@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allocetra-OTS in people with Organ Dysfunction Syndrome Sepsis, run by Enlivex Therapeutics Ltd. at 1 site in Israel.
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 6 inclusion and 12 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 19 May 2020. 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 Israel. 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. 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?
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.
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?
Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE (time frame: 28 days follow up). 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 NCT03925857, 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 19 May 2020.