Clinical study to assess the safety and preliminary efficacy of HCR040, a drug based on mesenchymal stem cells, in patients with acute respiratory distress syndrome. (included patients COVID-19)

Phase 1/2 clinical study to assess the feasibility, safety, tolerability and preliminary efficacy 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. (included patients COVID-19)

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002688-89-ES

Enrollment

Registered

2019-07-26

Start date

2019-12-10

Completion date

Unknown

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory distress syndrome

Interventions

Product Name: HCR040 Product Code: HCR040 Pharmaceutical Form: Suspension for injection INN or Proposed INN: HCR040 Current Sponsor code: HCR040 Other descriptive name: ALLOGENEIC ADIPOSE TISSUE-DERIV

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: – Men and women = 18 years – Patients with criteria of moderate to severe ARDS according to the Berlin Conference. – Patients with invasive mechanical ventilation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To assess the preliminary efficacy 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.;Primary end point(s): – Adverse events – Average stay in the ICU – SOFA index – Mechanical ventilation;Timepoint(s) of evaluation of this end point: 7, 14, 21, 28, 90, 120 and 365 post-administratión.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To assess the preliminary efficacy 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.;Primary end point(s): – Adverse events – Average stay in the ICU – SOFA index – Mechanical ventilation;Timepoint(s) of evaluation of this end point: 7, 14, 21, 28, 90, 120 and 365 post-administratión.

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Secondary

Measure	Time frame
Secondary end point(s): – Daily pulmonary mechanics – Determination of lung damage – Days free of vasopressors;Timepoint(s) of evaluation of this end point: 7, 14, 21, 28, 90, 120 y 365 post-administration.	—

Countries

Spain

Contacts

Public ContactBegoña Castro

Histocell S.L.

bcastro@histocell.com0034946567900

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026