← Back to Search

Stem Cell Therapy

Mesenchymal Stromal Cells for COVID-19

Phase 1 & 2
Waitlist Available
Led By LaQuisa Hill, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. up to 35 days.
Awards & highlights

Study Summary

This trial is enrolling at Houston Methodist Hospital (HMH)/Baylor College of Medicine (BCM) and are not shipping cells outside of BCM/HMH.

Eligible Conditions
  • COVID-19
  • Coronavirus
  • Acute Respiratory Distress Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. up to 35 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. up to 35 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Improvement by at Least Two Categories on a Six Category Ordinal Scale at Day 14
Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs)
Secondary outcome measures
All-cause Mortality
Clinical Status Determined by 6-point Ordinal Scale at Day 28
Duration of Hospital Stay
+6 more

Side effects data

From 2023 Phase 1 & 2 trial • 28 Patients • NCT04345601
100%
Anemia
70%
Blood bicarbonate decreased
70%
Hypophosphatemia
60%
Fever
60%
Aspartate aminotransferase increased
60%
Alanine aminotransferase increased
50%
Blood bilirubin increased
50%
Platelet count decreased
50%
Hypocalcemia
50%
Hyperphosphatemia
50%
Hypokalemia
40%
Hypernatremia
40%
Creatinine increased
30%
Hypercalcemia
30%
Hypoalbuminemia
30%
Respiratory, thoracic and mediastinal disorders - Other, specify:Hypercapnia
30%
White blood cell decreased
30%
Hyponatremia
20%
Constipation
20%
Headache
20%
Anxiety
20%
Hyperkalemia
20%
Hypoxia
20%
Lymphocyte count decreased
10%
Pneumothorax
10%
Abdominal pain
10%
Acute kidney injury
10%
Ileus
10%
Cardiac arrest
10%
Multi-organ failure
10%
Anorexia
10%
Hypothermia
10%
Delirium
10%
Diarrhea
10%
Rectal hemorrhage
10%
Fatigue
10%
Febrile neutropenia
10%
Nausea
10%
Depression
10%
Eosinophilia
10%
Seizure
10%
Lung infection
10%
Sepsis
10%
Rash maculo-papular
10%
Confusion
10%
Hypertension
10%
Cardiac troponin I increased
10%
Fungemia
10%
INR increased
10%
Hypermagnesemia
10%
Hypotension
10%
Urinary tract infection
10%
Neutrophil count decreased
10%
Peripheral sensory neuropathy
10%
Activated partial thromboplastin time prolonged
10%
Fall
10%
Epistaxis
10%
CPK increased
10%
Hematoma
10%
Skin and subcutaneous tissue disorders - Other, specify:rash - unspecified
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mesenchymal Stromal Cells (MSCs)
Safety Run In
Control Group

Trial Design

3Treatment groups
Experimental Treatment
Group I: Safety Run InExperimental Treatment1 Intervention
The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care.
Group II: Mesenchymal stromal cellsExperimental Treatment1 Intervention
Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion.
Group III: Control GroupExperimental Treatment1 Intervention
Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remestemcel-L
FDA approved

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,347 Total Patients Enrolled
3 Trials studying COVID-19
414 Patients Enrolled for COVID-19
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,224 Total Patients Enrolled
9 Trials studying COVID-19
1,774 Patients Enrolled for COVID-19
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,789 Total Patients Enrolled
1 Trials studying COVID-19
4 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)
LaQuisa Hill 2021. "Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04345601.
~7 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top