What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease include anti-inflammatory drugs, immunosuppressants, biologics, and corticosteroids. Anti-inflammatory drugs like aminosalicylates can cause nausea, vomiting, and headaches. Immunosuppressants such as azathioprine may lead to increased infection risk and liver toxicity. Biologics, including TNF inhibitors like infliximab, can cause infusion reactions, infections, and rare instances of lymphoma. Corticosteroids are associated with weight gain, osteoporosis, and increased infection risk. Exosome therapy from mesenchymal stem cells, similar to ExoFlo, is still under investigation, but potential side effects may include immune reactions and infection risks, although they are generally considered to have fewer side effects compared to live cell therapies.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of Crohn's Disease, primarily focusing on anti-inflammatory and immunomodulatory effects. These include TNF inhibitors like infliximab (Remicade) and adalimumab (Humira), integrin receptor antagonists like vedolizumab (Entyvio), and interleukin inhibitors like ustekinumab (Stelara). While exosome therapy from mesenchymal stem cells, such as ExoFlo, is still under investigation and not yet FDA-approved, it represents a novel approach with potential anti-inflammatory and regenerative benefits, similar to the mechanisms targeted by existing biologic therapies.

What other types of research exist?

Promising novel alternatives to ExoFlo for Crohn's Disease patients include: 1) Fecal Microbiota Transplantation (FMT), which has shown potential in small observational studies for inducing remission in diversion colitis, a condition related to Crohn's Disease. 2) Infliximab, an anti-TNF agent, which has been used to treat refractory cases of diversion colitis. 3) Probiotics, which have demonstrated improvement in inflammation and symptoms in a randomized controlled trial for diversion colitis. These therapies may offer anti-inflammatory benefits and should be discussed with a healthcare provider.

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Exosome Therapy

ExoFlo for Perianal Fistulas

Phase 1 & 2

Recruiting

Research Sponsored by Direct Biologics, LLC

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 12 months

Awards & highlights

Study Summary

This trial tests a potential medicine for a type of Crohn's Disease that affects the anus and rectum.

Who is the study for?

This trial is for adults aged 18-75 with Crohn's Disease who have perianal fistulas that didn't improve after surgery or those not suitable for surgery. They must have stable medical therapy for CD and failed at least one prior treatment. Exclusions include recent cancer, certain infections, severe health conditions, pregnancy, breastfeeding, MR contraindications like claustrophobia or implants.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of ExoFlo injections compared to saline injections in treating perianal fistulas in Crohn's Disease patients. It aims to see if ExoFlo can help where other treatments haven't worked.See study design

What are the potential side effects?

While specific side effects of ExoFlo are not listed here, similar treatments may cause injection site reactions, potential infection risks due to immune system impact, allergic reactions or discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and Feasibility

Secondary outcome measures

Healing

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

Constipation

Hyperglycaemia

Leukocytosis

Anaemia

Pyrexia

Agitation

Myalgia

Hypoalbuminaemia

Hypophosphataemia

Thrombocytopenia

Type 2 Diabetes Mellitus

Atrial Fibrillation

Upper Respiratory Tract Infection

Fluid Overload

Pneumonia

Confusional State

Hypertension

Embolism

Sepsis

Acute Kidney Injury

Multiple Organ Dysfunction Syndrome

Hypothermia

Hyperphosphataemia

Nasal Congestion

Atrial Flutter

Musculoskeletal Chest Pain

Bradycardia

Myocardial Ischaemia

Tachycardia

Hypocalcaemia

Oedema Peripheral

Nausea

Encephalopathy

Oropharyngeal Pain

Diarrhoea

Diabetes Mellitus

Pharyngeal Haemorrhage

Pneumothorax

Fall

Fungal Skin Infection

Malnutrition

Fungaemia

Hypernatraemia

Rales

Syncope

Cough

Abdominal Pain

Pancreatitis

Renal Ischemia

Renal Tubular Necrosis

Blood Glucose Increased

Acidosis

Septic Shock

Dyspepsia

Wound Infection

Troponin I Increased

Dehydration

Epistaxis

Enterococcal Infection

100%

80%

60%

40%

20%

Study treatment Arm

Experimental Dose 1

Placebo

Experimental Dose 2

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 3: TreatmentExperimental Treatment1 Intervention

Local injection of 30 mL of ExoFlo on Day 0 and Month 3

Group II: Cohort 2: TreatmentExperimental Treatment1 Intervention

Local injection of 30 mL of ExoFlo on Day 0

Group III: Cohort 1: TreatmentExperimental Treatment1 Intervention

Local injection of 15 mL of ExoFlo on Day 0

Group IV: Cohort 1: PlaceboPlacebo Group1 Intervention

Local injection 15 mL of normal saline on Day 0

Group V: Cohort 2: PlaceboPlacebo Group1 Intervention

Local injection 30 mL of normal saline on Day 0

Group VI: Cohort 3: PlaceboPlacebo Group1 Intervention

Local injection 30 mL of normal saline on Day 0 and Month 3

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ExoFlo

2020

Completed Phase 2

~110

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease include anti-inflammatory drugs, immune system suppressors, antibiotics, and biologic therapies. Anti-inflammatory drugs like corticosteroids reduce inflammation in the digestive tract. Immune system suppressors, such as azathioprine, target the immune response that causes inflammation. Biologic therapies, including TNF inhibitors like infliximab, block specific proteins involved in inflammation. Exosome therapy from mesenchymal stem cells, like ExoFlo, offers anti-inflammatory and regenerative properties by delivering cytokines and growth factors that reduce tissue injury and promote healing. These mechanisms are crucial for Crohn's Disease patients as they help manage chronic inflammation, promote tissue repair, and improve overall quality of life.

The therapeutic potential of stem cell-derived exosomes in the ulcerative colitis and colorectal cancer.Mesenchymal stem cell exosome: a novel stem cell-based therapy for cardiovascular disease.

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Who is running the clinical trial?

Direct Biologics, LLCLead Sponsor

10 Previous Clinical Trials

1,253 Total Patients Enrolled

Amy Lightner, MDStudy DirectorDirect Biologics, LLC

18 Previous Clinical Trials

1,588 Total Patients Enrolled

Bill AranaStudy DirectorDirect Biologics, LLC

9 Previous Clinical Trials

1,233 Total Patients Enrolled

~12 spots leftby Dec 2024

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