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15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 8 weeks after that to week 46 for Ulcerative Colitis

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

Study Summary

This trialtests a new therapy using stem cells to treat ulcerative colitis, a chronic bowel disease. 70 weeks, multi-site, open label.

Eligible Conditions
  • Ulcerative Colitis
  • Inflammatory Bowel Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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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
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PL8177
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Study Objectives

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

70 Weeks
Feasibility of intravenous ExoFlo in subjects with moderately to severely active Ulcerative colitis who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.
Measurement of subject's C-reactive protein (CRP)
Number of subjects with improving disease-specific health-related quality of life after receiving intravenous ExoFlo.
Safety of intravenous ExoFlo in subjects with moderately to severely active Ulcerative colitis who have failed, or are intolerant, or have a contraindication 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 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 UC, or study drug-related adverse event leading to discontinuation from the study.
70 weeks
Measurement of subject fecal calprotectin
Measurement of subject fecal lactoferrin
Number of adverse events in subjects who received intravenous ExoFlo in those subjects with moderately to severely active Ulcerative colitis who have failed or are intolerant to one or more monoclonal antibodies.
Number of subjects who tolerate intravenous ExoFlo in those subjects with moderately to severely active Ulcerative colitis who have failed or are intolerant to one or more monoclonal antibodies.
Number of subjects with improvement with intravenous ExoFlo in inducing clinical remission in those subjects with moderately to severely active Ulcerative colitis who have failed or are intolerant to one or more monoclonal antibodies.
Number of subjects with improvement with intravenous ExoFlo in inducing clinical response in those subjects with moderately to severely active Ulcerative colitis 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 or response at week 6 and week 46.

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
15ml of ExoFlo at Day 0, 2, 4, Week 2, Week 6, and every 8 weeks after that to week 46
2
PL8177
1
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Trial Design

2 Treatment Groups

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

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: 15ml of ExoFlo at Day 0, 2, 4 Week 2, 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, 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, 6, and every 4 weeks after that to week 46
Biological
Experimental Group · 1 Intervention: ExoFlo · Intervention Types: Biological
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 · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can have taken certain medications in the past, but you must stop taking certain types of medication for at least 8 weeks before starting the trial.
You have had ulcerative colitis for at least 6 months, and your symptoms have not improved with medical treatment.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - 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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