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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

No Placebo-Only Group

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

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My Crohn's disease is severe and not responding to treatment.

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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:

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I have had three or more surgeries to remove parts of my small intestine.

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I have tuberculosis, whether active or not.

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I have had part of my colon surgically removed.

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I have been diagnosed with primary sclerosing cholangitis.

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I have a narrow section in my colon that a standard scope can't pass through.

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I have a known blood clotting disorder.

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I am unable to understand and give consent for treatment.

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I have a confirmed diagnosis of HIV, Hepatitis B, or Hepatitis C.

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I needed emergency surgery for severe colitis.

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I have high bilirubin levels and liver disease.

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I cannot stop taking corticosteroids.

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I had emergency surgery for severe bleeding in my colon within the last 6 months.

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I currently have an active C. difficile infection in my colon.

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I have been diagnosed with a type of colitis.

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I have ulcerative colitis or a type of colitis that's not clearly defined.

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My biopsy shows I have colon cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6 and week 46

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

Anaemia

Leukocytosis

Hyperglycaemia

Constipation

Pyrexia

Agitation

Pneumonia

Embolism

Hypertension

Multiple Organ Dysfunction Syndrome

Sepsis

Hypoalbuminaemia

Thrombocytopenia

Atrial Fibrillation

Type 2 Diabetes Mellitus

Fluid Overload

Hypophosphataemia

Upper Respiratory Tract Infection

Myalgia

Confusional State

Acute Kidney Injury

Hypothermia

Septic Shock

Dyspepsia

Cough

Nasal Congestion

Rales

Fungal Skin Infection

Bradycardia

Pancreatitis

Musculoskeletal Chest Pain

Encephalopathy

Renal Ischemia

Renal Tubular Necrosis

Pneumothorax

Atrial Flutter

Myocardial Ischaemia

Tachycardia

Blood Glucose Increased

Diabetes Mellitus

Abdominal Pain

Diarrhoea

Nausea

Oropharyngeal Pain

Pharyngeal Haemorrhage

Fall

Hypocalcaemia

Oedema Peripheral

Fungaemia

Wound Infection

Hypernatraemia

Hyperphosphataemia

Malnutrition

Syncope

Acidosis

Troponin I Increased

Dehydration

Epistaxis

Enterococcal Infection

100%

80%

60%

40%

20%

Study treatment Arm

Experimental Dose 1

Placebo

Experimental Dose 2

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 18Eligibility criteria met