Acute Respiratory Distress SyndromePhase 1/2NCT04289194
Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome
A Phase 1/2 study testing HCR040 (Phase 1) and HCR040 (Phase 2) in people with Acute Respiratory Distress Syndrome, run by Histocell, S.L. at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- HCR040 (Phase 1) and HCR040 (Phase 2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Dec 2019to 27 Feb 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Fundación Jiménez Díaz
Madrid, 28040
About this study
Official title: Phase 1/2 Clinical Study to Assess the Feasibility, Safety, Tolerability and Preliminary Efficacy of the Administration of HCR040, Allogeneic Adipose-derived Adult Mesenchymal Stem Cells, in Acute Respiratory Distress Syndrome
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.
Read the detailed description
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
- Acute Respiratory Distress Syndrome
- Being tested
- HCR040 (Phase 1), Placebo (Phase 2), HCR040 (Phase 2)
- Keywords
- Acute Respiratory Distress Syndrome, mesenchymal stem cells, anti-inflammation, allogenic, ARDS, acute lung injury, cell therapy
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCR040 (Phase 1)Drug
Also called Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2
(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)Drug
Also called Saline solution
(Phase 2) Intravenous administration of vehicle solution
HCR040 (Phase 2)Drug
Also called Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2
(Phase 2) Intravenous administration of the maximum tolerated dose (1 million cells/kg or 2 million cells/kg)
| Study group | Role | What they receive |
|---|---|---|
| HCR040 (Phase 1) | Experimental | Participants with moderate to severe acute respiratory distress syndrome (6 patients) Receives: Drug: HCR040 (Phase 1) |
| Control group (Phase 2) | Placebo comparator | Participants with moderate to severe acute respiratory distress syndrome (10 patients) Receives: Drug: Placebo (Phase 2) |
| HCR040 (Phase 2) | Experimental | Participants with moderate to severe acute respiratory distress syndrome (10 patients) Receives: Drug: HCR040 (Phase 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events as a measure of safety and tolerability of a single dose of HCR040 when administered by intravenous injection
Measured: One year
Secondary outcomes (8)
Average stay in the Intensive Care Unit (ICU) 28 days after the administration of HCR040
Measured: Day 28
Sequential Organ Failure Assessment (SOFA) index at 3, 7, 14, 21, and 28 days after the administration of HCR040
SOFA index from 0 to 4 where lower scores represent improvement
Measured: Day 28
Mechanical ventilation-free days 28 days after the administration of HCR040
Measured: Day 28
Percent mortality 28 days after the administration of HCR040
Measured: Day 28
Daily pulmonary mechanics values (Ppl, DP, CRS)
Measured: One year
Determination of lung damage using the Murray scale at day 3, 7, 14 and 28 after the administration of HCR040
Murray scale from 0 to 4 where lower scores represent improvement
Measured: Day 28
Vasopressor-free days 28 days after the administration of HCR040
Measured: Day 28
ICU-free days 28 days after the administration of HCR040
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start10 Dec 2019
- Primary completion16 Aug 2021
- Study completion27 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Histocell, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fermin Labayen Beraza, MD, Principal investigator, Hospital de Cruces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289194
- Sponsor's protocol ID
- ALICELL-CT-01
- Other IDs
- 2019-002688-89, 2019
- Status last verified
- Feb 2022
- First submitted
- 26 Feb 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Clinical Study to Assess the Feasibility, Safety, Tolerability and Preliminary Efficacy of the Administration of HCR040, Allogeneic Adipose-derived Adult Mesenchymal Stem Cells, in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04289194
- Acronym / sponsor ID
- ALICELL-CT-01
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, mesenchymal stem cells, anti-inflammation, allogenic, ARDS, acute lung injury, cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Histocell, S.L.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HCR040 (Phase 1) | Experimental | Drug: HCR040 (Phase 1)Participants with moderate to severe acute respiratory distress syndrome (6 patients) |
| Control group (Phase 2) | Placebo comparator | Drug: Placebo (Phase 2)Participants with moderate to severe acute respiratory distress syndrome (10 patients) |
| HCR040 (Phase 2) | Experimental | Drug: HCR040 (Phase 2)Participants with moderate to severe acute respiratory distress syndrome (10 patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCR040 (Phase 1)Also: Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2(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) | Drug | HCR040 (Phase 1) |
| Placebo (Phase 2)Also: Saline solution(Phase 2) Intravenous administration of vehicle solution | Drug | Control group (Phase 2) |
| HCR040 (Phase 2)Also: Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2(Phase 2) Intravenous administration of the maximum tolerated dose (1 million cells/kg or 2 million cells/kg) | Drug | HCR040 (Phase 2) |
Primary outcome
Number of adverse events as a measure of safety and tolerability of a single dose of HCR040 when administered by intravenous injection
Time frame: One year
8 secondary outcomes
Average stay in the Intensive Care Unit (ICU) 28 days after the administration of HCR040
Time frame: Day 28
Sequential Organ Failure Assessment (SOFA) index at 3, 7, 14, 21, and 28 days after the administration of HCR040
Time frame: Day 28
Mechanical ventilation-free days 28 days after the administration of HCR040
Time frame: Day 28
Percent mortality 28 days after the administration of HCR040
Time frame: Day 28
Daily pulmonary mechanics values (Ppl, DP, CRS)
Time frame: One year
Determination of lung damage using the Murray scale at day 3, 7, 14 and 28 after the administration of HCR040
Time frame: Day 28
Vasopressor-free days 28 days after the administration of HCR040
Time frame: Day 28
ICU-free days 28 days after the administration of HCR040
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fermin Labayen Beraza, MD principal investigator
Hospital de Cruces
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HCR040 (Phase 1) and HCR040 (Phase 2) in people with Acute Respiratory Distress Syndrome, run by Histocell, S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events as a measure of safety and tolerability of a single dose of HCR040 when administered by intravenous injection (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.