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
Overview
- Phase
- Phase 1
- Intervention
- HCR040 (Phase 1)
- Conditions
- Acute Respiratory Distress Syndrome
- Sponsor
- Histocell, S.L.
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Number of adverse events as a measure of safety and tolerability of a single dose of HCR040 when administered by intravenous injection
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
HCR040 (Phase 1)
Participants with moderate to severe acute respiratory distress syndrome (6 patients)
Intervention: HCR040 (Phase 1)
Control group (Phase 2)
Participants with moderate to severe acute respiratory distress syndrome (10 patients)
Intervention: Placebo (Phase 2)
HCR040 (Phase 2)
Participants with moderate to severe acute respiratory distress syndrome (10 patients)
Intervention: HCR040 (Phase 2)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Average stay in the Intensive Care Unit (ICU) 28 days after the administration of HCR040(Day 28)
- Daily pulmonary mechanics values (Ppl, DP, CRS)(One year)
- Determination of lung damage using the Murray scale at day 3, 7, 14 and 28 after the administration of HCR040(Day 28)
- Vasopressor-free days 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)
- ICU-free days 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)