NCT04289194

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

Completed Phase 1, PHASE2 Last updated 28 February 2024

What this trial tests

Phase 1, PHASE2 trial testing HCR040 (Phase 1) in Acute Respiratory Distress Syndrome in 26 participants. Completed in 27 February 2022.

Timeline

10 December 2019

Primary endpoint
16 August 2021

27 February 2022

Quick facts

Lead sponsor	Histocell, S.L.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	26
Start date	10 December 2019
Primary completion	16 August 2021
Estimated completion	27 February 2022
Sites	2 locations across Spain

Drugs / interventions tested

• HCR040 (Phase 1) — full drug profile →
• Placebo (Phase 2) — full drug profile →
• HCR040 (Phase 2) — full drug profile →

Conditions studied

• Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →

Sponsor

Histocell, S.L. — full company profile →

Who can join

18 and older, any sex, with Acute Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal stem/stromal cells as a valuable source for the treatment of immune-mediated disorders.
   Markov A, Thangavelu L, Aravindhan S, Zekiy AO, et al · · 2021 · cited 174× · PMID 33736695 · DOI 10.1186/s13287-021-02265-1
2. Cell therapies in the clinic.
   Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
3. Current status of mesenchymal stem cell therapy for immune/inflammatory lung disorders: Gleaning insights for possible use in COVID-19.
   Yen BL, Yen ML, Wang LT, Liu KJ, et al · · 2020 · cited 55× · PMID 32526079 · DOI 10.1002/sctm.20-0186
4. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
5. Human Mesenchymal Stem/Stromal Cells in Immune Regulation and Therapy.
   Mezey É. · · 2022 · cited 28× · PMID 35298659 · DOI 10.1093/stcltm/szab020
6. Clinical applications of mesenchymal stromal cell-based therapies for pulmonary diseases: An Update and Concise Review.
   Chen X, Wang F, Huang Z, Wu Y, et al · · 2021 · cited 23× · PMID 34220313 · DOI 10.7150/ijms.59218
7. Review of Trials Currently Testing Stem Cells for Treatment of Respiratory Diseases: Facts Known to Date and Possible Applications to COVID-19.
   Majolo F, da Silva GL, Vieira L, Timmers LFSM, et al · · 2021 · cited 11× · PMID 32827081 · DOI 10.1007/s12015-020-10033-6
8. Stem Cell-based therapies for COVID-19-related acute respiratory distress syndrome.
   Ngai HW, Kim DH, Hammad M, Gutova M, et al · · 2022 · cited 1× · PMID 35426198 · DOI 10.1111/jcmm.17265