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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2022-02-27

Brief Summary

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The main objective of the study is to assess the feasibility, safety, and tolerability of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome.

Detailed Description

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HCR040 is an investigational medicinal product whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2.

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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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HCR040 (Phase 1)

Participants with moderate to severe acute respiratory distress syndrome (6 patients)

Group Type EXPERIMENTAL

HCR040 (Phase 1)

Intervention Type DRUG

(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)

Group Type PLACEBO_COMPARATOR

Placebo (Phase 2)

Intervention Type DRUG

(Phase 2) Intravenous administration of vehicle solution

HCR040 (Phase 2)

Participants with moderate to severe acute respiratory distress syndrome (10 patients)

Group Type EXPERIMENTAL

HCR040 (Phase 2)

Intervention Type DRUG

(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)

Intervention Type DRUG

Placebo (Phase 2)

(Phase 2) Intravenous administration of vehicle solution

Intervention Type DRUG

HCR040 (Phase 2)

(Phase 2) Intravenous administration of the maximum tolerated dose (1 million cells/kg or 2 million cells/kg)

Intervention Type DRUG

Other Intervention Names

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Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2 Saline solution Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2

Eligibility Criteria

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Inclusion Criteria

* Men and women ≥ 18 years
* 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

* Participation in a previous clinical study within 28 days prior to the ARDS situation
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Histocell, S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Countries

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Spain

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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