Clinical trial NCT02952131: Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease
Official title: Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Inflammatory Bowel Diseases
Keywords: IBD,Crohn's,Ulcerative Bowel; Diverticulitis;IBS;UC
Lead sponsor: Healeon Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Terry, Glenn C., M.D.
First posted: 2016-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety: Inflammatory Bowel Disease
timeFrame: 12 months Evaluate Function and Adverse Events
Secondary outcomes:
measure: Efficacy: Quality of life index , Inflammatory Bowel Disease Questionnaire(IBD-QoL)
timeFrame: 1 month, 6 month, 1 year
measure: Change from Baseline in C Reactive Protein (CRP)
timeFrame: 0, 2 weeks, 8 weeks, 12 weeks
measure: Efficacy: Change in Baseline of Modified Truelove-Witts Score (MTW)
timeFrame: 0, 4 weeks, 12 weeks
measure: Efficacy: Change in Baseline in Lichtiger Index
timeFrame: 0, 12 weeks, 6 months
Other outcomes:
Locations:
city: Stevensville
country: United States
facility: Regenevita LLC
state: Montana
Study officials:
affiliation: Healeon Medical Inc
name: Robert W Alexander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Global Alliance for Regenerative Medicine (GARM)
name: Glenn C Terry, MD
role: STUDY_DIRECTOR
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