Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome

NCT04289194 | Completed Phase 1 DMC

• 2 other identifiers: ALICELL-CT-012019-002688-89
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; mesenchymal stem cells; anti-inflammation; allogenic; ARDS; acute lung injury; cell therapy

Outcome Measures

Primary Outcomes (1)

• Number of adverse events as a measure of safety and tolerability of a single dose of HCR040 when administered by intravenous injection

  One year

Secondary Outcomes (8)

• Average stay in the Intensive Care Unit (ICU) 28 days after the administration of HCR040

  Day 28

• Sequential Organ Failure Assessment (SOFA) index at 3, 7, 14, 21, and 28 days after the administration of HCR040

  Day 28

• Mechanical ventilation-free days 28 days after the administration of HCR040

  Day 28

• Percent mortality 28 days after the administration of HCR040

  Day 28

• Daily pulmonary mechanics values (Ppl, DP, CRS)

  One year

Study Arms (3)

HCR040 (Phase 1)

EXPERIMENTAL

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

Drug: HCR040 (Phase 1)

Control group (Phase 2)

PLACEBO COMPARATOR

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

Drug: Placebo (Phase 2)

HCR040 (Phase 2)

EXPERIMENTAL

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

Drug: HCR040 (Phase 2)

Interventions

HCR040 (Phase 1) 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)

Also known as: Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2

HCR040 (Phase 1)

Placebo (Phase 2) DRUG

(Phase 2) Intravenous administration of vehicle solution

Also known as: Saline solution

Control group (Phase 2)

HCR040 (Phase 2) DRUG

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

Also known as: Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2

HCR040 (Phase 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Histocell, S.L.: lead

Study Sites (2)

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Interventions

Clinical Trials, Phase I as Topic; Heart Rate; Clinical Trials, Phase II as Topic; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Fermin Labayen Beraza, MD

  Hospital de Cruces

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: December 10, 2019
• Primary Completion: August 16, 2021
• Study Completion: February 27, 2022
• Last Updated: February 28, 2024

Record last verified: 2022-02

Locations

ES (2)