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Stem Cell Therapy
Fat-Derived Stem Cell Therapy for Inflammatory Bowel Disease (ADcSVF-IBD Trial)
Phase 1 & 2
Waitlist Available
Led By Robert W Alexander, MD
Research Sponsored by Healeon Medical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Negative pregnancy test for women of childbearing age (menarche to menopause)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 6 month, 1 year
Awards & highlights
ADcSVF-IBD Trial Summary
This trial is to study the use of a person's own fat cells to treat IBD.
Who is the study for?
This trial is for individuals with Inflammatory Bowel Disease diagnosed at least 6 months ago. It's open to adults and minors under 18 with guardian approval. Participants must be able to consent, not pregnant, and without severe IBD that prevents procedure tolerance or requires immediate steroids or surgery.Check my eligibility
What is being tested?
The study tests the use of one's own fat-derived stem cells (AD-cSVF) against IBD symptoms compared to a saline solution control group. The process includes lipoaspiration (fat removal) and then administering these cells intravenously.See study design
What are the potential side effects?
Potential side effects may include discomfort from lipoaspiration, typical risks associated with IV treatments like infection or inflammation at the injection site, and any unknown reactions related to stem cell therapy.
ADcSVF-IBD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant.
ADcSVF-IBD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month, 6 month, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 6 month, 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: Inflammatory Bowel Disease
Secondary outcome measures
Change from Baseline in C Reactive Protein (CRP)
Efficacy: Change in Baseline in Lichtiger Index
Efficacy: Change in Baseline of Modified Truelove-Witts Score (MTW)
+1 moreADcSVF-IBD Trial Design
3Treatment groups
Experimental Treatment
Group I: Normal Saline IV Arm 3Experimental Treatment1 Intervention
Normal Saline IV with AD-cSVF cells
Group II: Lipoaspiration Arm 1Experimental Treatment1 Intervention
Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat
Group III: AD-cSVF Arm 2Experimental Treatment1 Intervention
Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lipoaspiration
2022
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Healeon Medical IncLead Sponsor
8 Previous Clinical Trials
610 Total Patients Enrolled
Terry, Glenn C., M.D.INDIV
4 Previous Clinical Trials
360 Total Patients Enrolled
Robert W Alexander, MDPrincipal InvestigatorHealeon Medical Inc
6 Previous Clinical Trials
770 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need immediate treatment for my condition, as judged by my doctor.I have had surgery to remove part or all of my colon.I am under 18 and have consent from my guardians and the study's investigators.I am not pregnant.I was diagnosed with IBD at least 6 months ago.I haven't been in a drug trial or had cancer treatment in the last 6 months.I am 18 or older and have been diagnosed with IBD.My severe IBD prevents me from tolerating certain medical procedures.I am currently taking corticosteroids and need them to manage my condition.I am able to understand and consent to the study.
Research Study Groups:
This trial has the following groups:- Group 1: Lipoaspiration Arm 1
- Group 2: AD-cSVF Arm 2
- Group 3: Normal Saline IV Arm 3
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 seniors welcome to enroll in this program?
"The age requirements to participate in this trial are between 18 and 85 years old."
Answered by AI
Are there still open slots for volunteers in this research project?
"The clinical trial in question is not, at this time, accepting patients. Based on the information available from clinicaltrials.gov, which last updated this study on August 1st 2022, the study has not been recruiting since 2016. There are, however, 204 other trials that are currently looking for participants."
Answered by AI
Recent research and studies
The LancetJournal
Inflammatory Bowel Disease: Clinical Aspects and Established and Evolving TherapiesOther Trials to Consider
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