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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

Tracking Information
First Submitted Date  ICMJE April 29, 2021
First Posted Date  ICMJE May 3, 2021
Last Update Posted Date June 15, 2021
Actual Study Start Date  ICMJE June 14, 2021
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
Composite endpoint [ Time Frame: at 15 days after intervention ]
rate of use of mechanical ventilation (i.e. need for intubation) or death
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2021)
Composite endpoint: rate of use of mechanical ventilation (i.e. need for intubation) or death [ Time Frame: at 15 days after intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • 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
  • Survival [ Time Frame: day 7, 15 and 30 ]
    Rate of patients alive at Day 7, Day 15 and Day 30
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2021)
  • Clinical status evaluation [ Time Frame: day 7, 15 and 30 ]
    assessed by the 9-point ordinal scale
  • Survival [ Time Frame: day 7, 15 and 30 ]
  • Time to clinical improvement [ Time Frame: time from randomization to either an improvement of 1 point on the 9-point ordinal scale or discharge from hospital ]
    assessed by the 9-point ordinal scale
  • Duration of hospitalization and ICU stay [ Time Frame: From enrolment to discharge or ICU transfer or death ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells
Official Title  ICMJE 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
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)
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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
  • Other: Placebo
    Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group
Study Arms  ICMJE
  • Experimental: Allogeneic Wharton's jelly-MSCs (WJ-MSC)
    Intravenous administration, 1 dose, for 20 minutes
    Intervention: Biological: Allogeneic Wharton's jelly-MSCs (WJ-MSC)
  • Placebo Comparator: Placebo
    Intravenous administration, 1 dose, for 20 minutes
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2021)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ines Colmegna 514-934-1934 ext 35639 ines.colmegna@mcgill.ca
Contact: James Martin 514-934-1934 ext 76172 james.martin@mcgill.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04869397
Other Study ID Numbers  ICMJE 2021-6954
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ines Colmegna, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ines Colmegna Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP