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    Clinical Trial Results:
    Conditioned Autologous Serum Therapy (Orthokine) on the dorsal root ganglion in patients with chronic radiculalgia (RADISAC)

    Summary
    EudraCT number
    		 2021-005124-38
    Trial protocol
    		 ES  
    Global end of trial date
    30 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2025
    First version publication date
    29 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RADISAC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    DARYD
    Sponsor organisation address
    Sabino Arana 38, Barcelona, Spain,
    Public contact
    DARYD, DARYD, martahoms7@gmail.com
    Scientific contact
    DARYD, DARYD, martahoms7@gmail.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
    07 Mar 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether therapy with conditioned autologous serum on the dorsal root ganglion reduces neuropathic pain in patients with persistent lower limb radiculalgia
    Protection of trial subjects
    The principal investigator was the contact person for the patients, who made the first visit, the procedures and the 30-day, 3-month, 6-month and 12-month follow-ups. Nevertheless, the patients had a Pain Unit telephone number and an email at their disposal to contact the principal investigator whenever they needed to.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason, Scientific research
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    46
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 70
    Number of subjects completed
    		 70

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental group
    Arm description
    		 Treatment aply: Puulse Radiofrecuency + Autologus Conditioned Serum
    Arm type
    		 Experimental

    Investigational medicinal product name
    Authologus Conditioned Serum
    Investigational medicinal product code
    PS-8229-2010
    Other name
    Authologus conditioned Serum (Orthokine)
    Pharmaceutical forms
    Injection, Solution for infusion in pre-filled syringe, Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Infiltration
    Dosage and administration details
    4mL

    Arm title
    		 Control Group
    Arm description
    		 Treatment aply: Puulse Radiofrecuency + 0'9% Saline Serum
    Arm type
    		 Placebo

    Investigational medicinal product name
    Serum Saline
    Investigational medicinal product code
    Other name
    0'9% serum saline
    Pharmaceutical forms
    Solution for infusion, Solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    4mL

    Number of subjects in period 1
    		Experimental group Control Group
    Started
    35
    35
    Completed
    35
    35

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Experimental group
    Reporting group description
    		 Treatment aply: Puulse Radiofrecuency + Autologus Conditioned Serum

    Reporting group title
    Control Group
    Reporting group description
    		 Treatment aply: Puulse Radiofrecuency + 0'9% Saline Serum

    Subject analysis set title
    Control group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patiets included in study recived RDF therapy on the DRG for 8 minutes (45 V) of the root affects. At the end of the RFP therapy, a 3mL dose of autologus serum therapy (AST, Orthokine) will be administered on the DRG in patients of exeprimental group; and a 3mL dose of 0.9% physiological saline in patients in the contol group

    Subject analysis set title
    Experimental group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patiets included in study recived RDF therapy on the DRG for 8 minutes, (45 V) of the root affects. At the end of the RFP therapy, a 3mL dose of autologus serum therapy (AST, Orthokine) will be administered on the DRG in patients of exeprimental group; and a 3mL dose of 0.9% physiological saline in patients in the control group

    Primary: Level of Pain (VSG)

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    End point title
    		 Level of Pain (VSG)
    End point description
    End point type
    Primary
    End point timeframe
    30 days / 3 months / 6 months /12 months
    End point values
    		 Control group Experimental group
    Number of subjects analysed
    35
    35
    Units: scale of pain (0-10)
        arithmetic mean (standard deviation)
    6.64 ( 2.37 )
    3.16 ( 2.02 )
    Statistical analysis title
    		 Mixed linear model
    Statistical analysis description
    To determine the evolution for each of the variables during the 4 follow-up visits (30 days, 3 months, 6 months and 12 months), a mixed model for repeated measures or a generalized linear model for repeated measures will be carried out, as appropriate. All analyzes will be carried out by intention to treat (ITT)
    Comparison groups
    Experimental group v Control group
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [1] - significant p value < 0.05

    Secondary: Neuropathic pain

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    End point title
    		 Neuropathic pain
    End point description
    End point type
    Secondary
    End point timeframe
    30 days/ 3 months/ 6 months / 12 months
    End point values
    		 Experimental group Control Group Control group Experimental group
    Number of subjects analysed
    35
    35
    35
    35
    Units: DN4 (0-10)
        arithmetic mean (standard deviation)
    5.15 ( 1.73 )
    5.17 ( 2.49 )
    3.61 ( 2.43 )
    4.39 ( 2.25 )
    Statistical analysis title
    		 Mixed linear model
    Comparison groups
    Control group v Experimental group
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Variability estimate
    Standard deviation
    Notes
    [2] - Significant p< 0.05

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Throughout the period in which patients received treatment and subsequent follow-up visits, both complications and adverse effects were recorded.
    Adverse event reporting additional description
    Additionally, apart from the scheduled visits at 30 days, 3 months, 6 months, and 12 months, patients had direct access to a phone line for the unit, allowing them to contact the principal investigator in case they experienced any adverse effects.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SEFV-H: SISTEMA ESPA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Adverse events Experimental Group
    Reporting group description
    		 Patients of the Experimental Group who experienced adverse effects.

    Reporting group title
    Adverse events control group
    Reporting group description
    		 Patients of the control group who experienced adverse effects.

    Serious adverse events
    		 Adverse events Experimental Group Adverse events control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.02%
    Non-serious adverse events
    		 Adverse events Experimental Group Adverse events control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    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: There were no no-serious adverse events.

    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.
    At the 12-month follow-up, a lower number of patients were observed during the analysis, as some of them, due to persistent symptoms, preferred to pursue other types of treatment and were therefore excluded from the final analysis.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38007491
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    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
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