What side effects are associated with this type of intervention?

Common treatments for Inflammatory Bowel Disease (IBD) include corticosteroids, biologic agents, and immunomodulators. Corticosteroids can cause serious side effects like bone fractures, hypertension, and hyperglycemia. Biologic agents, such as anti-TNF drugs, may increase infection risk, cause infusion reactions, and lead to antibody development against the drug. Immunomodulators can result in bone marrow suppression, liver toxicity, and heightened infection risk. These side effects underscore the need for safer treatments like Adipose-Derived Stem/Stromal Cells (AD-cSVF), which are being studied for their potential to modulate immune responses, promote tissue repair, and reduce inflammation.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Inflammatory Bowel Disease (IBD), which includes Crohn's Disease and Ulcerative Colitis. These biologics primarily target immune responses to reduce inflammation and promote tissue repair. Notable examples include anti-TNF agents such as infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia). Vedolizumab (Entyvio), an integrin receptor antagonist, and ustekinumab (Stelara), an IL-12 and IL-23 antagonist, are also approved for IBD treatment. These therapies aim to modulate the immune system and reduce chronic inflammation, similar to the potential benefits being studied with Adipose-Derived Stem/Stromal Cells (AD-cSVF).

What other types of research exist?

Promising novel alternatives to Adipose-Derived Stem/Stromal Cells (AD-cSVF) for Inflammatory Bowel Disease patients include: 1) Mesenchymal Stem Cells (MSCs) from sources other than adipose tissue, such as bone marrow or umbilical cord, which have shown potential in modulating immune responses and promoting tissue repair. 2) Biologic agents like Vedolizumab and Ustekinumab, which target specific pathways in the immune response and have demonstrated efficacy in clinical trials. 3) Granulocyte/Macrophage Colony-Stimulating Factor (GM-CSF), which has been investigated for its role in enhancing immune function and tissue repair in IBD. These alternatives offer potential benefits in managing IBD by addressing inflammation and promoting healing.

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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

Must not have

Patients with history of colectomy

Severe IBD preventing tolerance of procedures needed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 6 month, 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment using special cells taken from a patient's own fat tissue. These cells are used to help reduce inflammation and promote healing in patients with Inflammatory Bowel Disease (IBD), including Ulcerative Colitis and Crohn's Disease. The goal is to find a more effective treatment that addresses the root causes of the disease rather than just the symptoms.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery to remove part or all of my colon.

Select...

My severe IBD prevents me from tolerating certain medical procedures.

Select...

I am currently taking corticosteroids and need them to manage my condition.

Select...

I am able to understand and consent to the study.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 6 month, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety: Inflammatory Bowel Disease

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met

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

Common treatments for Inflammatory Bowel Disease (IBD) such as mesalamine, glucocorticoids, and biologic agents like infliximab and adalimumab primarily work by modulating the immune response, reducing inflammation, and promoting tissue repair. Mesalamine acts locally in the gut to reduce inflammation, while glucocorticoids suppress the overall immune response to decrease inflammation. Biologic agents target specific components of the immune system, such as tumor necrosis factor (TNF), to prevent inflammatory processes. Treatments like Adipose-Derived Stem/Stromal Cells (AD-cSVF) are being studied for their potential to modulate immune responses, promote tissue repair, and reduce inflammation, which could offer a more targeted and regenerative approach to managing IBD. These mechanisms are crucial for IBD patients as they aim to control chronic inflammation, promote healing of the intestinal lining, and improve overall quality of life.