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Mesenchymal Stem Cell Therapy
ExoFlo for Ulcerative Colitis
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
The following medications/therapies must have been discontinued before first administration of study agent: TNF-antagonist therapy (e.g. infliximab, etanercept, certolizumab, adalimumab, golimumab, vedolizumab, ustekinumab) for at least 8 weeks. Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks. 6-thioguanine (6-TG) must have been discontinued for at least 4 weeks. Rectal corticosteroids (ie, corticosteroids [including budesonide] administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks. Rectal 5-ASA compounds (ie, 5-ASAs administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks. Parenteral corticosteroids for at least 2 weeks. Total parenteral nutrition (TPN) for at least 2 weeks. Antibiotics for the treatment of UC (eg, ciprofloxacin, metronidazole, or rifaximin) for at least 2 weeks. No colonic dysplasia and malignancy as ruled out by colonoscopy within 30 days of MSC delivery. Ability to comply with protocol. Competent and able to provide written informed consent. Stated willingness to comply with all study procedures and availability for the duration of the study. If patient is of reproductive capacity, willing to use adequate birth control measures while they are in the study
Ulcerative colitis of at least 6 months duration with medically refractory symptoms
Must not have
Fulminant colitis requiring emergency surgery
Patients taking anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix) to reduce the risk of bleeding/ hemarthrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 and week 46
Awards & highlights
Summary
This trial tests ExoFlo, a bone marrow cell-derived treatment, on patients with severe ulcerative colitis who haven't responded to other treatments. ExoFlo aims to reduce inflammation and heal the gut.
Who is the study for?
Adults aged 18-75 with medically refractory ulcerative colitis can join this trial. They must have tried certain medications without improvement and be on stable doses of others if used. Participants need to use birth control if applicable, not have colon cancer or dysplasia, and cannot be pregnant or breastfeeding.
What is being tested?
The trial is testing ExoFlo, a mesenchymal stem cell-derived product for treating ulcerative colitis that hasn't responded to standard treatments. It's an open-label Phase I study conducted at multiple sites over approximately 58 weeks per participant.
What are the potential side effects?
As this is a Phase I trial primarily assessing safety, specific side effects are not listed but may include typical reactions related to immune modulation such as infusion-related reactions, potential allergic responses, or other unforeseen complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had ulcerative colitis for over 6 months and my symptoms haven't improved with treatment.
Select...
I didn't improve after 8 weeks on specific drugs or can't take them due to side effects or health reasons.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I needed emergency surgery for severe colitis.
Select...
I am on blood thinners like warfarin or clopidogrel.
Select...
I have ulcerative colitis that affects more than just my colon.
Select...
I have a colon tumor and had a biopsy before surgery.
Select...
I had emergency surgery for severe bleeding in my colon within the last 6 months.
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 have been diagnosed with a type of colitis.
Select...
I have tuberculosis, whether active or not.
Select...
I currently have an active C. difficile infection in my colon.
Select...
I have had part of my colon surgically removed.
Select...
I cannot stop taking corticosteroids.
Select...
I have a known blood clotting disorder.
Select...
I have Crohn's colitis or indeterminate colitis.
Select...
I have had surgery to remove part of my small intestine.
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
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 ulcerative colitis 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 ulcerative colitis who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.
Secondary study objectives
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 or response at week 6 and week 46.
To evaluate the pharmacokinetics and pharmacodynamics of ExoFlo therapy, including changes in C-reactive protein (CRP) and fecal calprotectin.
+1 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%
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
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
The most common treatments for Ulcerative Colitis (UC) include mesalamine, corticosteroids, immunomodulators, and biologics. Mesalamine works by reducing inflammation directly in the colon lining.
Corticosteroids suppress the overall immune response to decrease inflammation. Immunomodulators like azathioprine alter the immune system to prevent it from attacking the colon.
Biologics, such as anti-TNF agents, target specific proteins involved in the inflammatory process. Emerging treatments like mesenchymal stem cell-derived extracellular vesicles (similar to ExoFlo) offer a novel approach by potentially modulating the immune response and promoting tissue repair.
These mechanisms are crucial for UC patients as they aim to reduce inflammation, promote healing, and maintain remission, thereby improving quality of life.
Emerging Therapies for Inflammatory Bowel Diseases.
Emerging Therapies for Inflammatory Bowel Diseases.
Find a Location
Who is running the clinical trial?
Direct Biologics, LLCLead Sponsor
10 Previous Clinical Trials
1,198 Total Patients Enrolled
Vikram Sengupta, MDPrincipal InvestigatorDirect Biologics
8 Previous Clinical Trials
1,162 Total Patients Enrolled
Amy Lightner, MDStudy DirectorDirect Biologics, LLC
18 Previous Clinical Trials
1,533 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had ulcerative colitis for over 6 months and my symptoms haven't improved with treatment.I needed emergency surgery for severe colitis.I have a CMV infection in my colon confirmed by a biopsy within the last 90 days.I have ulcerative colitis that affects more than just my colon.I have a colon tumor and had a biopsy before surgery.I had emergency surgery for severe bleeding in my colon within the last 6 months.I have not had any cancer, except for skin cancer, in the last 5 years.I am on blood thinners like warfarin or clopidogrel.I've been on a stable dose of my current medication for at least 4 weeks.I haven't had major heart issues or other serious health problems in the last 6 months.I am between 18 and 75 years old.I am unable to understand and give consent for treatment.I have a confirmed diagnosis of HIV, Hepatitis B, or Hepatitis C.I have been diagnosed with a type of colitis.I have tuberculosis, whether active or not.I currently have an active C. difficile infection in my colon.I have had part of my colon surgically removed.I cannot stop taking corticosteroids.I have a known blood clotting disorder.I didn't improve after 8 weeks on specific drugs or can't take them due to side effects or health reasons.I have stopped any monoclonal antibody treatments 8 weeks ago.I have Crohn's colitis or indeterminate colitis.I have had surgery to remove part of my small intestine.
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.
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