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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02952131
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : November 8, 2018
Terry, Glenn C., M.D.
Information provided by (Responsible Party):
Robert W. Alexander, MD, FICS, Healeon Medical Inc

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Procedure: Lipoaspiration Procedure: AD-cSVF Procedure: Normal Saline IV Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
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

Experimental: Normal Saline IV Arm 3
Normal Saline IV with AD-cSVF cells
Procedure: Normal Saline IV
Normal Saline IV containing AD-cSVF

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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%

  2. 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

  3. 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%

  4. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02952131

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Contact: Robert W Alexander, MD, MD 4067774477
Contact: Nancy Smith, MA, ORT 4067774477

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United States, Montana
Regenevita LLC Recruiting
Stevensville, Montana, United States, 59870
Contact: Nancy Smith, MA, ORT    406-777-4477   
Contact: Nancy L Smith, MA,ORT    4067774477   
Regenevita LLC Recruiting
Stevensville, Montana, United States, 59870
Contact: Glenn C Terry, MD    706-566-9141   
Contact: Heather Terry    17065669141   
Principal Investigator: Glenn C Terry, MD         
Principal Investigator: Robert W Alexander, MD         
Sponsors and Collaborators
Healeon Medical Inc
Terry, Glenn C., M.D.
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Principal Investigator: Robert W Alexander, MD Healeon Medical Inc
Study Director: Glenn C Terry, MD Global Alliance for Regenerative Medicine (GARM)

Publications of Results:
Other Publications:

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Responsible Party: Robert W. Alexander, MD, FICS, Principal Investigator, Healeon Medical Inc Identifier: NCT02952131     History of Changes
Other Study ID Numbers: RGV-GARM3
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert W. Alexander, MD, FICS, Healeon Medical Inc:
IBD,Crohn's,Ulcerative Bowel; Diverticulitis;IBS;UC

Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases