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Mesenchymal Stem Cell Therapy
ExoFlo for Ulcerative Colitis
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 and week 46
Awards & highlights
Study Summary
This trialtests a new therapy using stem cells to treat ulcerative colitis, a chronic bowel disease. 70 weeks, multi-site, open label.
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.Check my eligibility
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.See study design
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.
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 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 outcome measures
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%
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%
Hyperphosphataemia
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%
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
Bill AranaStudy DirectorDirect Biologics, LLC
9 Previous Clinical Trials
1,259 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 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants in this clinical trial?
"According to clinicaltrials.gov, this trial is currently recruiting patients and was initially published on December 19th 2022. The research overview has been edited as recently as the same date."
Answered by AI
Who is the ideal participant for this research investigation?
"The current study, which is recruiting 10 participants, necessitates that potential candidates are between 18 and 75 years old and have a diagnosis of ulcerative colitis."
Answered by AI
Is this research protocol inclusive of senior citizens aged 85 and above?
"To meet the requirements of this medical experiment, potential participants must be aged between 18 and 75. In comparison, there are 71 research initiatives for people under 18 years old and 350 projects targeting those over 65."
Answered by AI
How many individuals are being trialed in this research program?
"Affirmative. Clinicaltrials.gov data indicates that this clinical trial is presently recruiting volunteers, which was first posted on December 19th 2022 and updated on the same date. A total of 10 individuals need to be recruited from 1 location for participation in the study."
Answered by AI
What adverse effects might one experience after taking 15ml of ExoFlo at Day 0, 2, 4 Week 2, 6 and every 8 weeks until week 46?
"This Phase 1 trial has limited data to demonstrate safety and efficacy, so the Power team assigned a rating of 1 when assessing 15ml doses of ExoFlo taken at Day 0, 2, 4 Week 2, 6, and every 8 weeks after that up to Week 46."
Answered by AI
What results is the clinical trial designed to yield?
"Sponsored by Direct Biologics, LLC., this clinical trial has a 70-week duration and measures the number of adverse events associated with intravenous ExoFlo treatment in patients who have failed or are intolerant to one or more monoclonal antibodies for moderately to severely active Ulcerative colitis. Secondary objectives assess C-reactive protein (CRP) levels along with the effectiveness of intravenous ExoFlo at inducing clinical response and improving disease-specific quality of life."
Answered by AI
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