Adipose Mesenchymal Cells for Abatement of SARS-CoV-2 Respiratory Compromise in COVID-19 Disease

NCT04352803 | Not Yet Recruiting Phase 1

• 1 other identifier: COVID-MSCIV
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate the safety and efficacy of autologous adipose-derived mesenchymal cells for treating confirmed or suspected patients with SARS-CoV-2 and compromised respiratory function requiring hospitalization. The hypothesis of the Study is autologous adipose-derived mesenchymal cells given IV to eligible patients will improve clinical outcomes of COVID 19 positive patients with severe pneumonia or ARDS by reducing or avoiding cytokine storm.

Conditions

Covid-19 Pneumonia; Cyotokine Storm

Keywords

Coronavirus; SARS-CoV-2; ARDS; Pandemic

Outcome Measures

Primary Outcomes (6)

• Safety - Incidence of unexpected adverse events

  Incidence of unexpected adverse events within 28 days following IV administration of MSCs.

  up to 28 days

• Efficacy - Frequency of progression to mechanical ventilation

  Changes in progression or rate of subjects progressing to mechanical ventilation

  up to 28 days

• Efficacy - Changes in length of mechanical ventilation

  Changes in time subjects remain on mechanical ventilation

  up to 28 days

• Efficacy - Changes in length of weaning of mechanical ventilation

  Changes in length of time subjects wean off of mechanical ventilation

  up to 28 days

• Efficacy - Changes in length of hospital stay

  Length of Hospital Stay

  up to 28 days

• Efficacy - Changes in mortality rate

  Mortality rate from all causes

  up to 28 days

Study Arms (2)

Autologous Adipose Derived Mesenchymal Cells

EXPERIMENTAL

Conventional treatment plus MSC's IV

Biological: Autologous Adipose MSC's

Untreated

NO INTERVENTION

Conventional treatment only

Interventions

Autologous Adipose MSC's BIOLOGICAL

Autologous Adipose Derived Mesenchymal Cells 500,000/kg IV

Autologous Adipose Derived Mesenchymal Cells

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of and less than 90
• COVID 19 diagnosis confirmed
• Ability to give informed consent
• Hospitalized

You may not qualify if:

• Mild Illness
• Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion, or headache. Rarely, patients may also present with diarrhea, nausea and vomiting.
• Pneumonia (uncomplicated):
• a. Adults with pneumonia but no signs of severe pneumonia AND NO need for supplemental oxygen
• Reported pregnant or positive pregnancy test
• Other chronic respiratory disorders such as COPD, emphysema, lung cancer, or cystic fibrosis
• BMI lower than 21
• Skinfold test \< 3 cm at harvest area
• Patients with Do-Not-Resuscitate orders that limit mechanical ventilation assistance in place at hospital admission
• Males and females \< 18 years of age
• Patients who are currently breastfeeding
• Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection viruses.
• History of systemic malignant neoplasms within the last 5 years.
• Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
• Participating in another clinical research study

Sponsors & Collaborators

• Regeneris Medical: lead

Related Publications (9)

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

  PMID: 32109013 BACKGROUND

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 BACKGROUND

• Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

  PMID: 31986261 BACKGROUND

• Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.

  PMID: 32081636 BACKGROUND

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 BACKGROUND

• Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

  PMID: 32192578 BACKGROUND

• Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging Dis. 2020 Mar 9;11(2):216-228. doi: 10.14336/AD.2020.0228. eCollection 2020 Apr.

  PMID: 32257537 BACKGROUND

• Mohammadzadeh A, Pourfathollah AA, Shahrokhi S, Hashemi SM, Moradi SL, Soleimani M. Immunomodulatory effects of adipose-derived mesenchymal stem cells on the gene expression of major transcription factors of T cell subsets. Int Immunopharmacol. 2014 Jun;20(2):316-21. doi: 10.1016/j.intimp.2014.03.003. Epub 2014 Apr 3.

  PMID: 24704622 BACKGROUND

• Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

  PMID: 11304456 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Ryan Welter, MD PhD

CONTACT

(508) 576-8325; r.welter@regenerismedical.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an Interventional, Prospective, Open label (Voluntary Assignment), single to multiple center expansion, unmatched controlled, Sequentially Interim analysis tested Trial

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2026
• Last Updated: April 21, 2020

Record last verified: 2020-04