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Trial record 1 of 5 for:    COVID-19 Infection Using Wharton's Jelly
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Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells (ProTrans19+)

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ClinicalTrials.gov Identifier: NCT04869397
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Ines Colmegna, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
This is a randomized phase II placebo controlled clinical trial. Active arm: Allogeneic Wharton's jelly derived MSCs (WJ-MSCs). Both groups will receive standard of care treatment for COVID (e.g. dexamethasone)

Condition or disease Intervention/treatment Phase
Covid19 Biological: Allogeneic Wharton's jelly-MSCs (WJ-MSC) Other: Placebo Phase 2

Detailed Description:

Allogeneic Wharton's jelly-MSCs (WJ-MSC) will be provided by NextCell Pharma under the commercial name of ProTrans®. ProTrans® will be administered at a fixed dose of 100 million cells per patient in a single infusion at bedside.

Placebo: Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group (NextCell Pharma).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Respiratory Complications Associated With COVID-19 Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): a Randomized Phase II Controlled Clinical Trial
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : July 30, 2022

Arm Intervention/treatment
Experimental: Allogeneic Wharton's jelly-MSCs (WJ-MSC)
Intravenous administration, 1 dose, for 20 minutes
Biological: Allogeneic Wharton's jelly-MSCs (WJ-MSC)

The product is provided cryopreserved by NextCell Pharma. The cells are frozen in cryobags at a concentration of 2 × 107 cells/ml in 5% Human Serum Albumin (HSA) and 10% dimethylsulfoxide (DMSO). One cryobag contains one dose. The bags are frozen in a controlled rate freezer and directly transferred to -190 ºC for storage until the time of infusion.

Cryobags are thawed at bedside and diluted in 100 ml of saline prior to administration. Cells will be delivered at a rate of 5 million cells per minute over a total of 20 minutes.

Other Name: Protrans

Placebo Comparator: Placebo
Intravenous administration, 1 dose, for 20 minutes
Other: Placebo
Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group




Primary Outcome Measures :
  1. Composite endpoint [ Time Frame: at 15 days after intervention ]
    rate of use of mechanical ventilation (i.e. need for intubation) or death


Secondary Outcome Measures :
  1. Clinical status evaluation assessed by the 9-point ordinal scale [ Time Frame: day 7, 15 and 30 ]
    Score 0. No clinical or virological evidence of infection. 1. No limitations of activities. 2. Ambulatory, limitation of activities. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, intubated and on mechanical ventilation. 7. Hospitalized, ventilation + additional organ support - pressors, RRT, ECMO, 8. Death

  2. Survival [ Time Frame: day 7, 15 and 30 ]
    Rate of patients alive at Day 7, Day 15 and Day 30

  3. Time to clinical improvement assessed by the 9-point ordinal scale [ Time Frame: time from randomization to either an improvement of 1 point on the 9-point ordinal scale or discharge from hospital ]
    Score 0. No clinical or virological evidence of infection. 1. No limitations of activities. 2. Ambulatory, limitation of activities. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, intubated and on mechanical ventilation. 7. Hospitalized, ventilation + additional organ support - pressors, RRT (Renal Replacement Therapy), ECMO, 8. Death

  4. Duration of hospitalization and ICU stay [ Time Frame: From enrolment to discharge or ICU transfer or death ]
    Length of hospitalization and ICU stay in days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 18 years-old or older
  • Laboratory-confirmed SARS-CoV-2 infection determined by reverse-transcription polymerase chain reaction (RT-PCR) prior to randomization
  • Hospitalized patients
  • Severe COVID-19 pneumonia defined as patients who cannot saturate > 96% on 4 L/min but are NOT on "non-invasive" ventilation nor invasive mechanical ventilation nor Extracorporeal membrane oxygenation (ECMO). Patients on high flow would be eligible if they receive treatment in a non-critical care unit only.
  • Use of contraception or acceptable birth control for the duration of the study in women of childbearing potential
  • Provision of written or verbal informed consent by the patient or designated substitute decision maker

Exclusion Criteria:

  • Inability to provide informed consent
  • Patients expected to survive less than 24 hours
  • Advanced directives of patient's wishes to refuse intubation.
  • Patients on mechanical ventilation
  • Pregnant women [pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test]
  • Breastfeeding
  • Weight > 100 kg or < 50 kg
  • Cancer not in remission or active serious illness unrelated to COVID-19.
  • Any of the following laboratory results at screening: Absolute neutrophil count (ANC) ≤ 1.0 x 109/L, Platelets (PLT) < 50 G /L, Alanine transaminase (ALT) or Aspartate transaminase (AST) > 5N, eGFR < 30 mL/min
  • Current documented bacterial infection
  • Known infection with Human immunodeficiency virus, Treponema pallidum, Hepatitis B antigen (serology consistent with previous vaccination and a history of vaccination is acceptable) or Hepatitis C
  • On-going therapy against tuberculosis, or exposed to tuberculosis or have travelled in areas with high risk of tuberculosis or mycosis within the last 3 months
  • Known allergies to a component of the ProTrans® product
  • Pre-existing chronic respiratory diseases requiring long-term oxygen therapy or severe pulmonary hypertension (PAPS >30 mm HG) or pulmonary fibrosis
  • Pre-existing cirrhosis with basal Child and Pugh of C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869397


Contacts
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Contact: Ines Colmegna 514-934-1934 ext 35639 ines.colmegna@mcgill.ca
Contact: James Martin 514-934-1934 ext 76172 james.martin@mcgill.ca

Locations
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Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Ines Colmegna, MD    514 934 1934 ext 35639    ines.colmegna@mcgill.ca   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Ines Colmegna Research Institute of the McGill University Health Centre
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Responsible Party: Ines Colmegna, Senior Researcher, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04869397    
Other Study ID Numbers: 2021-6954
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ines Colmegna, McGill University Health Centre/Research Institute of the McGill University Health Centre:
mesenchymal stromal cells
wharton's jelly
respiratory complication
biologics
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Lung Diseases
Respiratory Tract Diseases