Fat-Derived Stem Cell Therapy for Inflammatory Bowel Disease

(ADcSVF-IBD Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Healeon Medical Inc

Must not be taking: Corticosteroids

Disqualifiers: Severe IBD, Colectomy, Malignant disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently on corticosteroids and meet the criteria for cortico-dependency, you may not be eligible to participate.

Is fat-derived stem cell therapy safe for humans?

Research on fat-derived stem cell therapy, including studies on animals and humans, suggests it is generally safe. For example, a study on dogs with inflammatory bowel disease found no side effects after treatment, indicating it was well tolerated. ^{1 2 3 4 5}

How is the AD-cSVF treatment different from other treatments for inflammatory bowel disease?

AD-cSVF treatment is unique because it uses fat-derived stem cells, which have regenerative and immunoregulatory properties, offering a novel approach to managing inflammation and promoting healing in inflammatory bowel disease, unlike traditional treatments that primarily focus on suppressing symptoms. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment AD-cSVF for Inflammatory Bowel Disease?

Research shows that mesenchymal stem cells, which are similar to those derived from fat tissue, have been effective in improving symptoms of inflammatory bowel disease in animal models. These cells help heal damaged tissue and reduce inflammation, suggesting potential benefits for similar treatments like AD-cSVF. ^{2 4 7 8 9}

Who Is on the Research Team?

Robert W Alexander, MD

Principal Investigator

Healeon Medical Inc

Glenn C Terry, MD

Principal Investigator

Global Alliance for Regenerative Medicine (GARM)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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 haven't been in a drug trial or had cancer treatment in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous cellular therapy using AD-cSVF via Normal Saline IV

12 weeks

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits at 1 month, 6 months, and 1 year

Extension

Optional long-term follow-up to assess sustained efficacy and safety

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• AD-cSVF

Trial Overview 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.

How Is the Trial Designed?

Group I: Normal Saline IV Arm 3 Experimental Treatment 1 Intervention

Normal Saline IV with AD-cSVF cells

Group II: Lipoaspiration Arm 1 Experimental Treatment 1 Intervention

Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat

Group III: AD-cSVF Arm 2 Experimental Treatment 1 Intervention

Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)

Who Is Running the Clinical Trial?

Healeon Medical Inc

Lead Sponsor

Trials

9

Recruited

710+

Terry, Glenn C., M.D.

Collaborator

Trials

5

Recruited

460+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Combinatorial Intervention with Mesenchymal Stem Cells and Granulocyte Colony-Stimulating Factor in a Rat Model of Ulcerative Colitis. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Therapeutic application of mesenchymal stromal cells in murine models of inflammatory bowel disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Isolation of stem cell populations with trophic and immunoregulatory functions from human intestinal tissues: potential for cell therapy in inflammatory bowel disease. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Topical implantation of mesenchymal stem cells has beneficial effects on healing of experimental colitis in rats. [2008]

5. Germany pubmed.ncbi.nlm.nih.gov

Therapeutic potential of mature adipocyte-derived dedifferentiated fat cells for inflammatory bowel disease. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal injection of adipose-derived mesenchymal stem cells ameliorates TNBS-induced colitis in rats and prevents stenosis. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Stem Cell Therapy in Inflammatory Bowel Disease: A Review of Achievements and Challenges. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of allogeneic adipose tissue-derived mesenchymal stem cells for treatment of dogs with inflammatory bowel disease: Clinical and laboratory outcomes. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Stem cells as potential targeted therapy for inflammatory bowel disease. [2018]