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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

Atrial Flutter

Hyperphosphataemia

Nasal Congestion

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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are those aged less than 75 years old able to participate in this test?

"This clinical trial is only open to patients between 18 and 75 years of age. In contrast, there are 84 trials for those younger than 18 and 284 studies pertaining to individuals over 65."

Answered by AI

Are there still available slots for participants in this research study?

"According to the clinicaltrials.gov registry, this investigation is actively seeking participants. This trial was originally announced on August 28th 2023 and was revised recently on the 31st of that same month."

Answered by AI

Who is qualified to participate in this research initiative?

"This clinical trial is seeking 36 individuals aged 18-75 with perianal fistulas. Eligibility criteria include being a man or woman diagnosed with Crohn's disease for at least 6 months, having previously tried several treatments (antibiotics, immunomodulators, monoclonal antibodies) without success, prior failed surgical intervention within two weeks of enrolment in the study., medical therapy stability over 2 months prior to starting the new medication and ability to provide written informed consent."

Answered by AI

What is the current population of participants involved in this experiment?

"Confirmed. According to the clinicaltrials.gov website, this research project is currently recruiting participants; it was initially published on August 28th 2023 and recently updated on August 31st 2023. The team needs 36 individuals from one site to complete their study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of ExoFlo for the Treatment of Perianal Fistulas

2023. "Study of ExoFlo for the Treatment of Perianal Fistulas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05836883.

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