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    Clinical Trial Results:
    A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

    Summary
    EudraCT number
    		 2021-003273-66
    Trial protocol
    		 ES   FR   BE   GR   NL   IT  
    Global end of trial date
    16 Dec 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Jan 2026
    First version publication date
    31 Jul 2025
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Adding study results.
    Summary report(s)
    		 ENX-CL-02-002 CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    ENX-CL-02-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04612413
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Enlivex Therapeutics R&D Ltd.
    Sponsor organisation address
    14 Einstein St., Nes Ziona, Israel, 7403618
    Public contact
    Regulatory unit, Accelsiors CRO and Consultancy Services Ltd., +36 12990091, regulatory@accelsiors.com
    Scientific contact
    Regulatory unit, Accelsiors CRO and Consultancy Services Ltd., +36 12990091, regulatory@accelsiors.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Dec 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the safety and efficacy of different doses and regimens of Allocetra-OTS to that of Placebo in the treatment of organ failure in adult sepsis patients.
    Protection of trial subjects
    Personal Data was handled in accordance with the EU General Data Protection Regulation and local data protection laws.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    Belgium: 21
    Country: Number of subjects enrolled
    France: 52
    Country: Number of subjects enrolled
    Israel: 23
    Worldwide total number of subjects
    120
    EEA total number of subjects
    92
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    51
    From 65 to 84 years
    65
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: 16Dec2020 [FPFV (first patient, first visit)] to 16Dec2024 [LPLV (last patient, last visit)]. Recruitment territories: Israel, Serbia, Spain, France, Belgium, and the Netherlands.

    Pre-assignment
    Screening details
    		 Screening criteria had several variations depending on subject underlying disease (CAP, UTI, Acute Cholecystitis, Cholangitis, IAI and Skin or Soft Tissue Infection). No. of subjects screened for inclusion: 148. No. of subjects screen failures: 17. No. of subjects enrolled: 131. No. of subjects randomized: 131. Randomized but not treated: 11

    Period 1
    Period 1 title
    Main Study
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    All patients will be centrally randomized and assigned to study intervention within the Electronic Data Capture (EDC).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 - Placebo
    Arm description
    		 Solution containing 50% PlasmaLyte and 50% CryoStor5®.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400ml suspension for injection

    Arm title
    		 Cohort 2 - Allocetra-OTS 5x10^9 Cells
    Arm description
    		 Cohort 2; 5x10^9 cells in 200 mL solution + 200mL placebo solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allocetra-OTS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Type: Allogeneic cellular therapy. Dose formulation: Apoptotic cell suspension cryopreserved in a solution containing 50% PlasmaLyte and 50% CryoStor5®. Dosage level: 5x109 cells in 200 mL solution + 200mL placebo solution. Route of administration: IV infusion. Packaging and labeling: IP will be supplied as a kit of cryopreservation bags, each containing cells suspended in solution at a concentration of 2.5x109 cells per 100 mL solution. The kit will be labelled with a blinded label. Upon thawing, the IP bags and tubing will be covered by study unblinded personnel, to keep blinding.

    Arm title
    		 Cohort 3 - Allocetra-OTS 10x10^9 Cells
    Arm description
    		 Cohort 3; 10x10^9 cells in 400 mL solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allocetra-OTS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Type: Allogeneic cellular therapy. Dose formulation: Apoptotic cell suspension cryopreserved in a solution containing 50% PlasmaLyte and 50% CryoStor5®. Dosage level: 5x10^9 cells in 200 mL solution + 200mL placebo solution. Route of administration: IV infusion. Packaging and labeling: IP will be supplied as a kit of cryopreservation bags, each containing cells suspended in solution at a concentration of 2.5x10^9 cells per 100 mL solution. The kit will be labelled with a blinded label. Upon thawing, the IP bags and tubing will be covered by study unblinded personnel, to keep blinding.

    Arm title
    		 Cohort 4 - Allocetra-OTS Single or two doses of 10x10^9 cells
    Arm description
    		 Cohort 4; Single or two doses of 10x10^9 cells in 400 mL solution each.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allocetra-OTS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Type: Allogeneic cellular therapy. Dose formulation: Apoptotic cell suspension cryopreserved in a solution containing 50% PlasmaLyte and 50% CryoStor5®. Dosage level: 5x10^9 cells in 200 mL solution + 200mL placebo solution. Route of administration: IV infusion. Packaging and labeling: IP will be supplied as a kit of cryopreservation bags, each containing cells suspended in solution at a concentration of 2.5x10^9 cells per 100 mL solution. The kit will be labelled with a blinded label. Upon thawing, the IP bags and tubing will be covered by study unblinded personnel, to keep blinding.

    Number of subjects in period 1
    		Cohort 1 - Placebo Cohort 2 - Allocetra-OTS 5x10^9 Cells Cohort 3 - Allocetra-OTS 10x10^9 Cells Cohort 4 - Allocetra-OTS Single or two doses of 10x10^9 cells
    Started
    45
    17
    18
    40
    Completed
    32
    13
    12
    29
    Not completed
    13
    4
    6
    11
         Adverse event, serious fatal
    6
    3
    2
    8
         Consent withdrawn by subject
    2
    -
    2
    1
         Other
    -
    1
    2
    -
         Lost to follow-up
    5
    -
    -
    2
    Period 2
    Period 2 title
    Follow-up for efficacy
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 - Placebo
    Arm description
    		 Solution containing 50% PlasmaLyte and 50% CryoStor5®.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400ml suspension for injection

    Arm title
    		 Cohort 2 - Allocetra-OTS 5x10^9 Cells
    Arm description
    		 Cohort 2; 5x10^9 cells in 200 mL solution + 200mL placebo solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allocetra-OTS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Type: Allogeneic cellular therapy. Dose formulation: Apoptotic cell suspension cryopreserved in a solution containing 50% PlasmaLyte and 50% CryoStor5®. Dosage level: 5x109 cells in 200 mL solution + 200mL placebo solution. Route of administration: IV infusion. Packaging and labeling: IP will be supplied as a kit of cryopreservation bags, each containing cells suspended in solution at a concentration of 2.5x109 cells per 100 mL solution. The kit will be labelled with a blinded label. Upon thawing, the IP bags and tubing will be covered by study unblinded personnel, to keep blinding.

    Arm title
    		 Cohort 3 - Allocetra-OTS 10x10^9 Cells
    Arm description
    		 Cohort 3; 10x10^9 cells in 400 mL solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allocetra-OTS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Type: Allogeneic cellular therapy. Dose formulation: Apoptotic cell suspension cryopreserved in a solution containing 50% PlasmaLyte and 50% CryoStor5®. Dosage level: 5x10^9 cells in 200 mL solution + 200mL placebo solution. Route of administration: IV infusion. Packaging and labeling: IP will be supplied as a kit of cryopreservation bags, each containing cells suspended in solution at a concentration of 2.5x10^9 cells per 100 mL solution. The kit will be labelled with a blinded label. Upon thawing, the IP bags and tubing will be covered by study unblinded personnel, to keep blinding.

    Arm title
    		 Cohort 4 - Allocetra-OTS Single or two doses of 10x10^9 cells
    Arm description
    		 Cohort 4; Single or two doses of 10x10^9 cells in 400 mL solution each.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allocetra-OTS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Type: Allogeneic cellular therapy. Dose formulation: Apoptotic cell suspension cryopreserved in a solution containing 50% PlasmaLyte and 50% CryoStor5®. Dosage level: 5x10^9 cells in 200 mL solution + 200mL placebo solution. Route of administration: IV infusion. Packaging and labeling: IP will be supplied as a kit of cryopreservation bags, each containing cells suspended in solution at a concentration of 2.5x10^9 cells per 100 mL solution. The kit will be labelled with a blinded label. Upon thawing, the IP bags and tubing will be covered by study unblinded personnel, to keep blinding.

    Number of subjects in period 2
    		Cohort 1 - Placebo Cohort 2 - Allocetra-OTS 5x10^9 Cells Cohort 3 - Allocetra-OTS 10x10^9 Cells Cohort 4 - Allocetra-OTS Single or two doses of 10x10^9 cells
    Started
    32
    13
    12
    29
    Completed
    32
    0
    0
    29
    Not completed
    0
    13
    12
    0
         not included in mITT
    -
    13
    12
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 - Placebo
    Reporting group description
    		 Solution containing 50% PlasmaLyte and 50% CryoStor5®.

    Reporting group title
    Cohort 2 - Allocetra-OTS 5x10^9 Cells
    Reporting group description
    		 Cohort 2; 5x10^9 cells in 200 mL solution + 200mL placebo solution.

    Reporting group title
    Cohort 3 - Allocetra-OTS 10x10^9 Cells
    Reporting group description
    		 Cohort 3; 10x10^9 cells in 400 mL solution.

    Reporting group title
    Cohort 4 - Allocetra-OTS Single or two doses of 10x10^9 cells
    Reporting group description
    		 Cohort 4; Single or two doses of 10x10^9 cells in 400 mL solution each.

    Reporting group values
    		 Cohort 1 - Placebo Cohort 2 - Allocetra-OTS 5x10^9 Cells Cohort 3 - Allocetra-OTS 10x10^9 Cells Cohort 4 - Allocetra-OTS Single or two doses of 10x10^9 cells Total
    Number of subjects
    		 45 17 18 40 120
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 18 7 7 19 51
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
        From 65-90 years
    		 27 10 11 21 69
    Gender categorical
    Units: Subjects
        Female
    		 21 8 6 17 52
        Male
    		 24 9 12 23 68

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 - Placebo
    Reporting group description
    		 Solution containing 50% PlasmaLyte and 50% CryoStor5®.

    Reporting group title
    Cohort 2 - Allocetra-OTS 5x10^9 Cells
    Reporting group description
    		 Cohort 2; 5x10^9 cells in 200 mL solution + 200mL placebo solution.

    Reporting group title
    Cohort 3 - Allocetra-OTS 10x10^9 Cells
    Reporting group description
    		 Cohort 3; 10x10^9 cells in 400 mL solution.

    Reporting group title
    Cohort 4 - Allocetra-OTS Single or two doses of 10x10^9 cells
    Reporting group description
    		 Cohort 4; Single or two doses of 10x10^9 cells in 400 mL solution each.
    Reporting group title
    Cohort 1 - Placebo
    Reporting group description
    		 Solution containing 50% PlasmaLyte and 50% CryoStor5®.

    Reporting group title
    Cohort 2 - Allocetra-OTS 5x10^9 Cells
    Reporting group description
    		 Cohort 2; 5x10^9 cells in 200 mL solution + 200mL placebo solution.

    Reporting group title
    Cohort 3 - Allocetra-OTS 10x10^9 Cells
    Reporting group description
    		 Cohort 3; 10x10^9 cells in 400 mL solution.

    Reporting group title
    Cohort 4 - Allocetra-OTS Single or two doses of 10x10^9 cells
    Reporting group description
    		 Cohort 4; Single or two doses of 10x10^9 cells in 400 mL solution each.

    Primary: Primary Endpoint Efficacy

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    End point title
    		 Primary Endpoint Efficacy [1]
    End point description
    Change from Baseline in SOFA score throughout 28 days
    End point type
    Primary
    End point timeframe
    28 Days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Analysis of primary endpoint is not disclosed as this indication is not being further developed by the sponsor
    End point values
    		 Cohort 1 - Placebo Cohort 2 - Allocetra-OTS 5x10^9 Cells Cohort 3 - Allocetra-OTS 10x10^9 Cells Cohort 4 - Allocetra-OTS Single or two doses of 10x10^9 cells
    Number of subjects analysed
    37
    0 [2]
    0 [3]
    31
    Units: score
        number (not applicable)
    -6.1
    -4.3
    Notes
    [2] - Not included in mITT
    [3] - Not included in mITT
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs will be assessed at all study visits throughout 12 months from first treatment, unless the AE is a result of study procedure. Beyond Day 90 follow up visit the focus will be on AEs considered to be at least probably related to the study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non serious AEs were not recorded in this output

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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