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Status unknownNCT04352803Updated Apr 21, 2020

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

A Phase 1 interventional study of Autologous Adipose MSC's in Covid-19 Pneumonia and Cyotokine Storm, sponsored by Regeneris Medical. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by Regeneris Medical · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

While most patients with SARS-CoV-2 present with mild respiratory disease with the most common symptoms of fever and cough, approximately 14 % progress to severe pneumonia and ARDS.

The overall mortality rate is 2% but varies by country and age of the patient.

In COVID-19 ARDS standard supportive care and treatment for underlying illnesses remain the mainstay with limited success.

Numerous antiviral medications including remdesivir, lopinavir-ritonavir or lopinavir-ritonavir and interferon Beta-1a are in clinical trials but safety and efficacy remain unclear.

Inflammation associated with a cytokine storm begins at a local site and spreads throughout the body via systemic circulation. The lungs and other organs are damaged with progressive inflammation.

Mesenchymal cells offer the potential to treat viral infection both directly and through reducing the immune response. MSCs play a role as an immunomodulator, which is safe and effective as demonstrated in numerous clinical trials.

Mesenchymal cells are a potential privileged cell-based therapy in SARS-CoV-2. MSCs derived extracellular vesicles have demonstrated comparable and sometimes more effective effects in ameliorating lung inflammation and injury.

02

Conditions studied

  • Covid-19 Pneumonia
  • Cyotokine Storm

Keywords

  • Coronavirus
  • SARS-CoV-2
  • ARDS
  • Pandemic
03

In context

Coronavirus Infections

952 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's planned enrollment of 20 is below the median of 110 across 549 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Regeneris Medical is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female patients ≥ 18 years of and less than 90
  2. COVID 19 diagnosis confirmed
  3. Ability to give informed consent
  4. Hospitalized

Exclusion criteria

Exclusion Criteria:

  1. Mild Illness

    1. 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.
    2. The elderly and immunosuppressed candidates may present with atypical symptoms. Symptoms due to physiologic adaptations of pregnancy or adverse pregnancy events, such as e.g. dyspnea, fever, GI-symptoms or fatigue, may overlap with COVID-19 symptoms. Still, they will be excluded, unless they progress to Inclusion Criteria within 72 hours from recruitment.

  2. Pneumonia (uncomplicated):

    a. Adults with pneumonia but no signs of severe pneumonia AND NO need for supplemental oxygen

  3. Reported pregnant or positive pregnancy test
  4. Other chronic respiratory disorders such as COPD, emphysema, lung cancer, or cystic fibrosis
  5. BMI lower than 21
  6. Skinfold test \< 3 cm at harvest area
  7. Patients with Do-Not-Resuscitate orders that limit mechanical ventilation assistance in place at hospital admission
  8. Males and females \< 18 years of age
  9. Patients who are currently breastfeeding
  10. Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection viruses.
  11. History of systemic malignant neoplasms within the last 5 years.
  12. 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
  13. Participating in another clinical research study
  14. History of Bleeding disorder which in PI's opinion would render the patient unsuitable for the study
  15. PT (plasma) \< 9 or >11.6 seconds and in the opinion of the PI and attending physician that lipoaspiration would be contraindicated. May be eligible for re-screening if coagulopathy improves within 72 hours of consent
  16. PTT \< 23 or >32 seconds and in the opinion of the PI and attending physician that lipoaspiration would be contraindicated. May be eligible for re-screening if coagulopathy improves within 72 hours of consent
  17. Platelets count less than 70,0000
  18. History of DVT
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Autologous Adipose Derived Mesenchymal Cells

    Conventional treatment plus MSC's IV

    Biological: Autologous Adipose MSC's

  • No intervention
    Untreated

    Conventional treatment only

Interventions

  • BiologicalAutologous Adipose MSC's

    Autologous Adipose Derived Mesenchymal Cells 500,000/kg IV

06

What researchers measure

Primary outcomes

  1. Safety - Incidence of unexpected adverse events

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

    Time frame: up to 28 days

  2. Efficacy - Frequency of progression to mechanical ventilation

    Changes in progression or rate of subjects progressing to mechanical ventilation

    Time frame: up to 28 days

  3. Efficacy - Changes in length of mechanical ventilation

    Changes in time subjects remain on mechanical ventilation

    Time frame: up to 28 days

  4. Efficacy - Changes in length of weaning of mechanical ventilation

    Changes in length of time subjects wean off of mechanical ventilation

    Time frame: up to 28 days

  5. Efficacy - Changes in length of hospital stay

    Length of Hospital Stay

    Time frame: up to 28 days

  6. Efficacy - Changes in mortality rate

    Mortality rate from all causes

    Time frame: up to 28 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32109013 ↗
  • 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. PubMed 22797452 ↗
  • 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. PubMed 31986261 ↗
  • 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. PubMed 32081636 ↗
  • 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. PubMed 32031570 ↗
  • 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. PubMed 32192578 ↗
  • 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. PubMed 32257537 ↗
  • 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. PubMed 24704622 ↗
  • 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. PubMed 11304456 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04352803
Lead sponsor
Regeneris Medical
Responsible party
Sponsor
First posted
Apr 20, 2020
Start date
Apr 2020 (estimated)
Primary completion
Apr 2024 (estimated)
Completion
Apr 2026 (estimated)
Last update
Apr 21, 2020

Study contacts

Ryan Welter, MD PhD
Contact
r.welter@regenerismedical.com
(508) 576-8325

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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