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Mesenchymal Stem Cell Therapy
ExoFlo for Crohn's Disease
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 and week 46
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My Crohn's disease is severe and not responding to treatment.
Select...
I am capable of understanding and signing the consent form.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreSide effects data
From 2021 Phase 2 trial • 102 Patients • NCT0449324235%
Acute Respiratory Failure
26%
Anxiety
24%
Hypotension
24%
Hypokalaemia
15%
Respiratory Failure
12%
Cardiac Arrest
12%
Hyperkalaemia
9%
Constipation
9%
Hyperglycaemia
9%
Leukocytosis
9%
Anaemia
9%
Pyrexia
9%
Agitation
6%
Myalgia
6%
Hypoalbuminaemia
6%
Hypophosphataemia
6%
Thrombocytopenia
6%
Type 2 Diabetes Mellitus
6%
Atrial Fibrillation
6%
Upper Respiratory Tract Infection
6%
Fluid Overload
6%
Pneumonia
6%
Confusional State
6%
Hypertension
6%
Embolism
6%
Sepsis
6%
Acute Kidney Injury
6%
Multiple Organ Dysfunction Syndrome
6%
Hypothermia
3%
Atrial Flutter
3%
Nasal Congestion
3%
Musculoskeletal Chest Pain
3%
Bradycardia
3%
Myocardial Ischaemia
3%
Tachycardia
3%
Hypocalcaemia
3%
Oedema Peripheral
3%
Nausea
3%
Encephalopathy
3%
Oropharyngeal Pain
3%
Diarrhoea
3%
Diabetes Mellitus
3%
Hyperphosphataemia
3%
Pharyngeal Haemorrhage
3%
Pneumothorax
3%
Fall
3%
Fungal Skin Infection
3%
Malnutrition
3%
Fungaemia
3%
Hypernatraemia
3%
Rales
3%
Syncope
3%
Cough
3%
Abdominal Pain
3%
Pancreatitis
3%
Renal Ischemia
3%
Renal Tubular Necrosis
3%
Blood Glucose Increased
3%
Acidosis
3%
Septic Shock
3%
Dyspepsia
3%
Wound Infection
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
1,279 Total Patients Enrolled
Amy Lightner, MDStudy DirectorDirect Biologics, LLC
18 Previous Clinical Trials
1,614 Total Patients Enrolled
Vikram Sengupta, MDPrincipal InvestigatorDirect Biologics
8 Previous Clinical Trials
1,243 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had three or more surgeries to remove parts of my small intestine.I am on a stable dose of ≤20 mg/day of prednisone or equivalent for at least 4 weeks.I am on blood thinners or clopidogrel to lower bleeding risk.I have stopped taking certain medications as required.I have had part of my colon surgically removed.I've had a colonoscopy in the last 90 days that showed no signs of cancer or precancerous conditions.I have stopped any monoclonal antibody treatments 8 weeks ago.I have been diagnosed with primary sclerosing cholangitis.I have a narrow section in my colon that a standard scope can't pass through.I have a known blood clotting disorder.My budesonide dose has been the same for at least 2 weeks.I have tuberculosis, whether active or not.I have been on a stable dose of AZA, 6-MP, or MTX for at least 4 weeks.I am unable to understand and give consent for treatment.I haven't had any major health issues in the last 6 months.I have a confirmed diagnosis of HIV, Hepatitis B, or Hepatitis C.I needed emergency surgery for severe colitis.I am between 18 and 75 years old.My Crohn's disease is severe and not responding to treatment.I have been on a stable dose of oral 5-ASA for at least 4 weeks.I have high bilirubin levels and liver disease.I am capable of understanding and signing the consent form.I stopped taking AZA, 6-MP, or MTX at least 4 weeks ago.I cannot stop taking corticosteroids.I have a CMV infection in my colon confirmed by a biopsy within the last 90 days.I have had Crohn's colitis for over 6 months and treatments haven't worked or I can't take them.I had emergency surgery for severe bleeding in my colon within the last 6 months.I have had cancer, including melanoma, in the last 5 years.I currently have an active C. difficile infection in my colon.I have been diagnosed with a type of colitis.I have ulcerative colitis or a type of colitis that's not clearly defined.My biopsy shows I have colon cancer.
Research Study Groups:
This trial has the following groups:- Group 1: 15ml at Day 0, 2, 4, 30 ml at Week 2, Week 6, and every 4 weeks after to week 46
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment currently open?
"According to data on clinicaltrials.gov, this research is presently accepting participants; the trial was initially published on December 19th 2022 and has been modified since then."
Answered by AI
What kind of participants are suitable for inclusion in this investigation?
"Eligibility for this medical research requires candidates to have ileocolitis and be between 18 and 75 years of age. The investigators are hoping to enrol approximately 10 individuals in the study."
Answered by AI
Is eligibility for this clinical trial restricted to individuals aged 20 or over?
"According to the study's inclusion criteria, volunteers must be aged 18-75. For individuals below 18 or above 65 years old, there are 105 and 354 respective clinical studies available for participation."
Answered by AI
In what capacity are the participants of this medical experiment being treated?
"Absolutely. According to clinicaltrials.gov, this medical trial is actively seeking out participants for enrollment and was initially posted on December 19th 2022 with the most recent update occurring on that same date. The study necessitates 10 people from a single site to join in its experimentations."
Answered by AI
Is the FDA sign-off for a 15ml dose of ExoFlo administered at Day 0, 2, 4 Week 2, 6 and biweekly thereafter up to 46 weeks?
"Given the limited safety and efficacy data available for 15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 8 weeks up until week 46, our team at Power has assigned a score of 1 on a scale from 1 - 3."
Answered by AI
What are the outcomes that this clinical trial is aiming to accomplish?
"This trial, which has a duration of 70 weeks, is primarily assessing the feasibility of using intravenous ExoFlo for patients who have Crohn's disease and are unresponsive or intolerant to other monoclonal antibodies. The secondary objectives include measuring clinical response rate as well as improvements in health-related quality of life while also evaluating the pharmacokinetics and pharmacodynamics (including CRP, calprotectin levels, etc.)."
Answered by AI
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