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

Sponsor
Healeon Medical Inc (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02952131
Collaborator
Terry, Glenn C., M.D. (Other)
100
Enrollment
1
Location
3
Arms
103.6
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2016
Anticipated Primary Completion Date :
Aug 14, 2024
Anticipated Study Completion Date :
Jun 19, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Safety: Inflammatory Bowel Disease [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) [1 month, 6 month, 1 year]

    Comparison of response if it improves at least 30%

  2. Change from Baseline in C Reactive Protein (CRP) [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) [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 [0, 12 weeks, 6 months]

    Remission considered if reaching 0 point, and response if the score diminishes from pretreatment level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regenevita LLC Stevensville Montana United States 59870

Sponsors and Collaborators

  • Healeon Medical Inc
  • Terry, Glenn C., M.D.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Robert W. Alexander, MD, FICS, Principal Investigator, Healeon Medical Inc
ClinicalTrials.gov Identifier:
NCT02952131
Other Study ID Numbers:
  • RGV-GARM3
First Posted:
Nov 2, 2016
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Principal Investigator, Healeon Medical Inc
IBD,Crohn's,Ulcerative Bowel; Diverticulitis;IBS;UC
Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases

Study Results

No Results Posted as of Aug 3, 2022