Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome
NCT ID: NCT04289194
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
26 participants
INTERVENTIONAL
2019-12-10
2022-02-27
Brief Summary
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Detailed Description
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The main purpose of this study is to evaluate the safety and tolerability of a single administration of HCR040 using: a) two sequential escalating doses administered 96 hours post-injury to participants with moderate to severe acute respiratory distress syndrome (ARDS); and b) the determined maximum tolerated dose administered 96 hours post-injury to participants with moderate to severe ARDS. The study also includes initial exploration of efficacy.
Treatment is administered by intravenous injection.
The study has been divided into two phases:
Phase 1 (open label): 6 participants with moderate to severe ARDS will be included in 2 sequential cohorts.
Phase 2 (randomized, controlled, double-blind): 20 participants with moderate to severe ARDS will be randomly divided into two groups (control and treated).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HCR040 (Phase 1)
Participants with moderate to severe acute respiratory distress syndrome (6 patients)
HCR040 (Phase 1)
(Phase 1) Intravenous administration. Open label dose escalation, 3 patients in cohort 1 (1 million cells/kg) and 3 patients in cohort 2 (2 million cells/kg)
Control group (Phase 2)
Participants with moderate to severe acute respiratory distress syndrome (10 patients)
Placebo (Phase 2)
(Phase 2) Intravenous administration of vehicle solution
HCR040 (Phase 2)
Participants with moderate to severe acute respiratory distress syndrome (10 patients)
HCR040 (Phase 2)
(Phase 2) Intravenous administration of the maximum tolerated dose (1 million cells/kg or 2 million cells/kg)
Interventions
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HCR040 (Phase 1)
(Phase 1) Intravenous administration. Open label dose escalation, 3 patients in cohort 1 (1 million cells/kg) and 3 patients in cohort 2 (2 million cells/kg)
Placebo (Phase 2)
(Phase 2) Intravenous administration of vehicle solution
HCR040 (Phase 2)
(Phase 2) Intravenous administration of the maximum tolerated dose (1 million cells/kg or 2 million cells/kg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with criteria of moderate to severe ARDS according to the Berlin Conference.
* Berlin criteria of moderate to severe ARDS given simultaneously during the 24 hours prior to entry into the study
* Patients with invasive mechanical ventilation in controlled mode (VC, PC or VCRP) adjusted to Vt≤8 mL/kg, Ppl \<30 cmH2O and minimum PEEP of 8 cmH2O
Exclusion Criteria
* Administration of a previous cell therapy product in the 5 years prior to this ARDS clinical situation
* Inability to obtain Informed Consent
* Hemodynamic instability that contraindicates the intravenous cellular administration, within the defined time frame for inclusion in the study
* Alveolar hemorrhage or hemoptysis
* LTSV situation (Limitation of life support treatments)
* Major trauma in the previous 5 days
* Neoplastic processes at any time
* EPOC or severe home asthma or any other type of chronic respiratory disease requiring respiratory oxygen
* Known Child-Pugh liver disease score \> B9
* Pregnant women or women of childbearing age who are not using an adequate method of contraception, or who, if they are using it, are not willing to continue using it for the duration of the trial. If the patient is menopausal or sterile, it must be documented in the medical record
* Women who are breastfeeding if unwillingly to stop at the time of recruitment
* Pulmonary transplant
* Known grade III or IV pulmonary hypertension
* States of hypercoagulability
* History of DVP or PE in the last 6 months
18 Years
ALL
No
Sponsors
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Histocell, S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Fermin Labayen Beraza, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Cruces
Locations
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Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Fundación Jiménez Díaz
Madrid, , Spain
Countries
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Other Identifiers
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2019-002688-89
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALICELL-CT-01
Identifier Type: -
Identifier Source: org_study_id
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