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15ml of ExoFlo at Day 0, 2, 4, Week 2, Week 6, and every 8 weeks after that to week 46 for Crohn's Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Phillip Fleshner, MD, Los Angeles, CACrohn's Disease+2 MoreExoFlo - Biological
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Crohn's Disease
  • Inflammatory Bowel Disease
  • Irritable Bowel Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 10 Secondary · Reporting Duration: Week 6 and Week 46

70 Weeks
Feasibility of intravenous ExoFlo in subjects with moderately to severely active 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 moderately to severely active Crohn's disease who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.
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 pharmacokinetics and pharmacodynamics of ExoFlo therapy, including changes in C-reactive protein (CRP) and fecal calprotectin.
To evaluate treatment failure as defined by disease worsening, need for rescue medications or surgical intervention for treatment of CD, or study drug-related adverse event leading to discontinuation from the study.
70 weeks
monoclonal antibodies. • To evaluate the safety of intravenous ExoFlo in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to one or more monoclonal antibodies.
• 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 in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to one or more monoclonal antibodies.
• To evaluate the efficacy of intravenous ExoFlo in inducing clinical response in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to one or more monoclonal antibodies.
• To evaluate the feasibility of intravenous ExoFlo in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to one or more monoclonal antibodies.
• To evaluate the pharmacokinetics and pharmacodynamics of ExoFlo therapy, including changes in C-reactive protein (CRP), fecal calprotectin, fecal lactoferrin, and other pharmacodynamic biomarkers.
• To evaluate the safety of intravenous ExoFlo in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to one or more monoclonal antibodies.
Week 46
To evaluate the efficacy of intravenous ExoFlo in inducing clinical remission at week 6 and week 46.
To evaluate the efficacy of intravenous ExoFlo in inducing clinical response at week 6 and week 46.

Trial Safety

Safety Progress

1 of 3

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1
15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 8 weeks after that to week 46
1
Remestemcel-L
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Trial Design

4 Treatment Groups

15ml of ExoFlo at Day 0, 2, 4, Week 2, Week 6, and every 8 weeks after that to w...
1 of 4
15ml of ExoFlo at Day 0, 2, 4, Week 2, Week 6, and every 4 weeks after that to w...
1 of 4
15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 8 weeks after that to week 46
1 of 4
15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 4 weeks after that to week 46
1 of 4

Experimental Treatment

10 Total Participants · 4 Treatment Groups

Primary Treatment: 15ml of ExoFlo at Day 0, 2, 4, Week 2, Week 6, and every 8 weeks after that to week 46 · No Placebo Group · Phase 1

15ml of ExoFlo at Day 0, 2, 4, Week 2, Week 6, and every 8 weeks after that to week 46
Biological
Experimental Group · 1 Intervention: ExoFlo · Intervention Types: Biological
15ml of ExoFlo at Day 0, 2, 4, Week 2, Week 6, and every 4 weeks after that to week 46
Biological
Experimental Group · 1 Intervention: ExoFlo · Intervention Types: Biological
15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 8 weeks after that to week 46
Drug
Experimental Group · 1 Intervention: Bone Marrow MSC Derived Extracellular Vesicle Isolate · Intervention Types: Drug
15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 4 weeks after that to week 46
Drug
Experimental Group · 1 Intervention: Bone Marrow MSC Derived Extracellular Vesicle Isolate · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ExoFlo
2020
Completed Phase 2
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 6 and week 46

Who is running the clinical trial?

Direct Biologics, LLCLead Sponsor
9 Previous Clinical Trials
673 Total Patients Enrolled
Amy Lightner, MDStudy DirectorDirect Biologics, LLC
17 Previous Clinical Trials
1,008 Total Patients Enrolled
Vikram Sengupta, MDPrincipal InvestigatorDirect Biologics
8 Previous Clinical Trials
673 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have Crohn's colitis for at least 6 months and have not responded to at least one type of monoclonal antibody treatment. You may also be unable to tolerate or have a medical reason for not being able to receive monoclonal antibody therapy. The next step in treatment may be subtotal colectomy or an increase in medication.
You can have taken certain medications in the past, but you must stop taking any monoclonal antibody drugs for 8 weeks before participating in the study.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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.)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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