Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease (ADcSVF-IBD)

September 30, 2024 updated by: Robert W. Alexander, MD, FICS, Healeon Medical Inc

Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) is a group of inflammatory conditions of the small bowel and colon. Main types include Ulcerative Colitis and Crohn's Disease. Symptoms are often difficult to distinguish except for location and nature of changes. IBD complex arises with interaction of environmental, genetic factors, immunological responses, and chronic and recurring inflammation.

Many factor appear as contributory, but no single set of issues appear to explain the process. Microbiota, intestinal wall granulation or breach, dietary, genetic predisposition all appear to factors. Treatment is often reactive or suppressive medications, neither of which appears to reverse the disease processes. This study explores the value of a complex group of adipose-derived stem/stromal cells (AD-cSVF) in the disease process.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

IBD often presents clinically as abdominal pain, diarrhea (with and without blood), fever, weight loss, failure to thrive, and many related symptoms. Complications of the disorders may also include anemia, skin rashes, arthritis, severe chronic fatigue, and eye inflammatory changes.

It is felt that IBD disorders may be caused by combination of environmental, immune, genetic, and bacterial factors. Results of these issues produce a chronic inflammatory disorder, in which the immune system attacks the gastrointestinal tract, perhaps directed by certain microbial antigens. The group appears not to be a pure autoimmune disease reaction, but may relate to a immunodeficiency state.

There are no medications or surgical procedures that are known to cure the diseases. Most are aimed at reduction of symptoms, maintain remissions, and try to prevent relapses. Temporary anti-inflammatory medications may improve the acute process, followed by methotrexate or thiopurine to maintain remission states. Surgery appears important in cases of perforation, abscesses, obstructions, or cancer management.

Actual occurrence is unknown, as there are more than Crohn's Disease and Ulcerative Colitis which appear related. It is estimated that more than 35,000 deaths were reported in 2010. Crohn's Disease alone appears to affect 3.2 per 1000 people in Europe and North America alone.

The usual onset of symptoms may appear before actual diagnoses are made, with typical diagnoses occurring between 15-30 years of age. Lead by abdominal pain symptoms (usually lower right quadrant) and the recurrent periods of flare and remission. Many dietary, bacterial, antimicrobials, and environmental factors receive attention, some new interest in evaluating alternative therapeutic modalities to deal of issues of immune system. Use of the immune privileged cellular agents held within the AD-cSVF is proposed to help with the inflammatory contributors as well as the modulation of inflammation which favors chronic wound healing and avascular systems. Known to provide secretory antibiotic (ll-37) contributions, some thought of pro- and anti-microbials, may prove of value in those areas specifically. Cytokine and growth factors implications at the lesion sites remain to be poorly understood, but those experienced in biocellular regenerative therapies have experienced contributions to healing and prevention of recurrences of ulcerative skin lesions.

Harvest of autologous of adipose-derived tissue stromal vascular fraction (AD-tSVF) is a proven rich resource of microvascular stem/stromal cell elements with well documented growth factor and cytokine contributors. With the advent of safe, measurable, and efficacious and reproducible numbers in a closed isolation environment, the ability to isolate and concentrate a cell-only product. This AD-cSVF is capable of reintroduction into patients, via a Normal Saline Solution, via parenteral route.

This study is intended to evaluate the safety (adverse outcomes) and efficacy of using autologous cellular therapy in cases of IBD.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Stevensville, Montana, United States, 59870
        • Regenevita LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients, either sex 18 years and older with confirmed diagnosis of IBD
  • Patients, either sex younger than 18 years upon approval of responsible parties and agreement of investigators
  • Ability of patient to provide informed consent (or legal guardian)
  • IBD diagnosed at least 6 months earlier to therapy using usual criteria
  • Negative pregnancy test for women of childbearing age (menarche to menopause)

Exclusion Criteria:

  • Mental incapacity that prevents adequate understanding of study and associate procedures and providing informed consent
  • Severe IBD preventing tolerance of procedures needed
  • Patients with impaired systemic condition, according to investigator judgment, needs immediate corticosteroid or surgical intervention
  • Patients that fulfill criteria of cortico-dependency and in current treatment with corticosteroids
  • Patients with history of colectomy
  • Known history of alcohol, smoking dependence or additive substance abuse
  • History related malignant disease - including patients participating in clinical trial with investigational drug within 6 months
  • Patients with known history of allergies to any substance used in this protocol
  • Pregnant or breastfeeding females
  • Presence of severe concomitant disease, in investigators opinion threatens patient's well being or safety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal Saline IV Arm 3
Normal Saline IV with AD-cSVF cells
Procedure: Normal Saline IV
Normal Saline IV containing AD-cSVF
Experimental: Lipoaspiration Arm 1
Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat
Procedure: Lipoaspiration
Closed Syringe Harvesting Autologous Subdermal Fat
Experimental: AD-cSVF Arm 2
Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)
Procedure: AD-cSVF
Use of Centricyte 1000 to isolate adipose stem/stromal cells via centrifugation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Inflammatory Bowel Disease
Time Frame: 12 months Evaluate Function and Adverse Events
Inflammatory Bowel Disease to be addressed as occurrence or frequency of adverse event during study. Includes vital signs, complete blood count, and disease progression
12 months Evaluate Function and Adverse Events

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Quality of life index , Inflammatory Bowel Disease Questionnaire(IBD-QoL)
Time Frame: 1 month, 6 month, 1 year
Comparison of response if it improves at least 30%
1 month, 6 month, 1 year
Change from Baseline in C Reactive Protein (CRP)
Time Frame: 0, 2 weeks, 8 weeks, 12 weeks
Blood draw and laboratory measure of CRP as reflection of inflammatory baseline change
0, 2 weeks, 8 weeks, 12 weeks
Efficacy: Change in Baseline of Modified Truelove-Witts Score (MTW)
Time Frame: 0, 4 weeks, 12 weeks
Remission is considered if below 11, and response if it diminishes at least 30%
0, 4 weeks, 12 weeks
Efficacy: Change in Baseline in Lichtiger Index
Time Frame: 0, 12 weeks, 6 months
Remission considered if reaching 0 point, and response if the score diminishes from pretreatment level
0, 12 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healeon Medical Inc

Collaborators

Terry, Glenn C., M.D.

Investigators

  • Study Director: Glenn C Terry, MD, Global Alliance for Regenerative Medicine (GARM)
  • Principal Investigator: Robert W Alexander, MD, Healeon Medical Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2016

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

October 30, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimated)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGV-GARM3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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