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Stem Cell Therapy

ExoFlo for COVID-19

Phase 2
Waitlist Available
Led By Vikram Sengupta, MD
Research Sponsored by Direct Biologics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 18-85.
Provision of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 61 days
Awards & highlights

Study Summary

This trial will test the safety and efficacy of ExoFlo, a bone marrow mesenchymal stem cell-derived extracellular vesicle, as treatment for mild-moderate COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~61 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 61 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
Change in SARS-CoV-2 log viral load from baseline to Day=7
Secondary outcome measures
- Proportion of patients who required COVID-19 related hospitalization or Emergency Department Visit by Day 29
Change in viral load area under the curve (AUC) from baseline to Day=29
Proportion of patients showing symptom improvement or resolution Day=7, 11, 15

Side effects data

From 2021 Phase 2 trial • 102 Patients • NCT04493242
35%
Acute Respiratory Failure
26%
Anxiety
24%
Hypokalaemia
24%
Hypotension
15%
Respiratory Failure
12%
Hyperkalaemia
12%
Cardiac Arrest
9%
Leukocytosis
9%
Pyrexia
9%
Constipation
9%
Hyperglycaemia
9%
Anaemia
9%
Agitation
6%
Upper Respiratory Tract Infection
6%
Pneumonia
6%
Hypoalbuminaemia
6%
Hypophosphataemia
6%
Embolism
6%
Confusional State
6%
Sepsis
6%
Atrial Fibrillation
6%
Fluid Overload
6%
Myalgia
6%
Type 2 Diabetes Mellitus
6%
Hypertension
6%
Acute Kidney Injury
6%
Multiple Organ Dysfunction Syndrome
6%
Thrombocytopenia
6%
Hypothermia
3%
Fall
3%
Encephalopathy
3%
Oropharyngeal Pain
3%
Nausea
3%
Diabetes Mellitus
3%
Hypocalcaemia
3%
Rales
3%
Fungal Skin Infection
3%
Diarrhoea
3%
Pharyngeal Haemorrhage
3%
Myocardial Ischaemia
3%
Atrial Flutter
3%
Hyperphosphataemia
3%
Syncope
3%
Bradycardia
3%
Hypernatraemia
3%
Cough
3%
Tachycardia
3%
Pneumothorax
3%
Musculoskeletal Chest Pain
3%
Nasal Congestion
3%
Abdominal Pain
3%
Fungaemia
3%
Pancreatitis
3%
Renal Ischemia
3%
Renal Tubular Necrosis
3%
Blood Glucose Increased
3%
Acidosis
3%
Septic Shock
3%
Dyspepsia
3%
Oedema Peripheral
3%
Wound Infection
3%
Troponin I Increased
3%
Malnutrition
3%
Dehydration
3%
Epistaxis
3%
Enterococcal Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental Dose 1
Placebo
Experimental Dose 2

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 15ml ExoFloExperimental Treatment1 Intervention
15ml ExoFlo + 85ml normal saline
Group II: 10ml ExoFloExperimental Treatment1 Intervention
10ml ExoFlo + 90ml normal saline
Group III: PlaceboPlacebo Group1 Intervention
100ml normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ExoFlo
2020
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Direct Biologics, LLCLead Sponsor
10 Previous Clinical Trials
1,289 Total Patients Enrolled
3 Trials studying COVID-19
162 Patients Enrolled for COVID-19
Bill AranaStudy DirectorDirect Biologics, LLC
9 Previous Clinical Trials
1,269 Total Patients Enrolled
3 Trials studying COVID-19
162 Patients Enrolled for COVID-19
Vikram Sengupta, MDPrincipal InvestigatorDirect Biologics
8 Previous Clinical Trials
1,253 Total Patients Enrolled
2 Trials studying COVID-19
162 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.

Does this research involve test subjects that are senior citizens?

"The age limit for this clinical trial is 85 years old. So long as they are above 18, any patient can be enrolled."

Answered by AI

When can US patients expect to have access to ExoFlo?

"While there is evidence that ExoFlo is safe, it only received a 2 because this Phase 2 trial has not yet yielded data supporting efficacy."

Answered by AI

Are patients able to sign up for this test right now?

"Unfortunately, this specific study is not looking for any new participants as of now. According to the clinicaltrials.gov website, recruitment for this trial ended on August 23rd, 2022. Although this particular research project isn't presently recruiting, there are 1130 other studies that currently are."

Answered by AI

How many research facilities are currently running this trial?

"Right now, potential participants can choose from 6 different clinical trial sites. The locations are Fullerton, Sheffield and Austin plus 3 other cities. If you want to take part in this study, try to pick a location that is close to minimize travel."

Answered by AI

How can I sign up to take part in this research project?

"Up to 30 people suffering from covid-19 will be accepted into this trial, provided they are willing to commit to the study's procedures and are available for its entirety. In order to qualify, patients must also meet the following additional requirements: being between 18 and 85 years old, having a RT-PCR SARS-CoV-2 test in the last 3 days that came back positive, being 10 days or less from acute COVID-19 symptom onset, not being at high risk for progression to severe COVID=19, having received their final dose of vaccination more than 28 days ago (if applicable), being on <"

Answered by AI
~0 spots leftby Mar 2025