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Mesenchymal Stem Cell Therapy

ExoFlo for Crohn's Disease

Phase 1
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
Patient with medically refractory Crohn's disease as defined by a CDAI score ≥150 and/or SES-CD score ≥ 3
Competent and able to provide written informed consent
Must not have
Three or more prior small bowel resections
Active or latent tuberculosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 and week 46
Awards & highlights

Summary

This trialwill test a new stem cell-derived product to treat Crohn's disease in 70 patients over 24 months at multiple sites.

Who is the study for?
Adults aged 18-75 with severe Crohn's disease that hasn't improved with standard treatments, including monoclonal antibody therapy. Participants must have a specific score indicating active disease and be on stable doses of certain medications if used. They should not have had recent surgeries or infections, and those who can become pregnant must use birth control during the study.
What is being tested?
The trial is testing ExoFlo, an experimental treatment derived from bone marrow stem cells, for Crohn's Disease patients who haven't responded to other therapies. It's an open-label Phase I study conducted at multiple sites over approximately 58 weeks to assess safety and effectiveness.
What are the potential side effects?
As this is a Phase I trial primarily focused on safety, detailed side effects are not provided but may include typical reactions related to immune system modulation such as inflammation or infusion-related responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Crohn's disease is severe and not responding to treatment.
Select...
I am capable of understanding and signing the consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had three or more surgeries to remove parts of my small intestine.
Select...
I have tuberculosis, whether active or not.
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I have had part of my colon surgically removed.
Select...
I have been diagnosed with primary sclerosing cholangitis.
Select...
I have a narrow section in my colon that a standard scope can't pass through.
Select...
I have a known blood clotting disorder.
Select...
I am unable to understand and give consent for treatment.
Select...
I have a confirmed diagnosis of HIV, Hepatitis B, or Hepatitis C.
Select...
I needed emergency surgery for severe colitis.
Select...
I have high bilirubin levels and liver disease.
Select...
I cannot stop taking corticosteroids.
Select...
I had emergency surgery for severe bleeding in my colon within the last 6 months.
Select...
I currently have an active C. difficile infection in my colon.
Select...
I have been diagnosed with a type of colitis.
Select...
I have ulcerative colitis or a type of colitis that's not clearly defined.
Select...
My biopsy shows I have colon cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6 and week 46
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 and week 46 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of intravenous ExoFlo in subjects with medically refractory Crohn's disease who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.
Safety of intravenous ExoFlo in subjects with medically refractory Crohn's disease who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.
Secondary study objectives
To evaluate endoscopic remission and endoscopic response.
To evaluate the efficacy of intravenous ExoFlo in improving disease-specific health-related quality of life.
To evaluate the efficacy of intravenous ExoFlo in inducing clinical remission at week 6 and week 46.
+3 more

Side effects data

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

1Treatment groups
Experimental Treatment
Group I: 15ml at Day 0, 2, 4, 30 ml at Week 2, Week 6, and every 4 weeks after to week 46Experimental Treatment1 Intervention
IV administration of 15 mL study agent at Day 0, Day 2, Day 4 and 30 mL at Week 2, Week 6 and every 4 weeks thereafter to week 46 (total # doses = 15).
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
1,198 Total Patients Enrolled
Bill AranaStudy DirectorDirect Biologics, LLC
9 Previous Clinical Trials
1,178 Total Patients Enrolled
Amy Lightner, MDStudy DirectorDirect Biologics, LLC
18 Previous Clinical Trials
1,533 Total Patients Enrolled

Media Library

ExoFlo (Mesenchymal Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05130983 — Phase 1
Crohn's Disease Research Study Groups: 15ml at Day 0, 2, 4, 30 ml at Week 2, Week 6, and every 4 weeks after to week 46
Crohn's Disease Clinical Trial 2023: ExoFlo Highlights & Side Effects. Trial Name: NCT05130983 — Phase 1
ExoFlo (Mesenchymal Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130983 — Phase 1
~1 spots leftby Dec 2024
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