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

NCT02952131 | Suspended Phase 1 DMC

• 1 other identifier: RGV-GARM3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

IBD,Crohn's,Ulcerative Bowel; Diverticulitis;IBS;UC

Outcome Measures

Primary Outcomes (1)

• Safety: Inflammatory Bowel Disease

  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 Outcomes (4)

• Efficacy: Quality of life index , Inflammatory Bowel Disease Questionnaire(IBD-QoL)

  1 month, 6 month, 1 year

• Change from Baseline in C Reactive Protein (CRP)

  0, 2 weeks, 8 weeks, 12 weeks

• Efficacy: Change in Baseline of Modified Truelove-Witts Score (MTW)

  0, 4 weeks, 12 weeks

• Efficacy: Change in Baseline in Lichtiger Index

  0, 12 weeks, 6 months

Study Arms (3)

Lipoaspiration Arm 1

EXPERIMENTAL

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

Procedure: Lipoaspiration

AD-cSVF Arm 2

EXPERIMENTAL

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

Procedure: AD-cSVF

Normal Saline IV Arm 3

EXPERIMENTAL

Normal Saline IV with AD-cSVF cells

Procedure: Normal Saline IV

Interventions

Lipoaspiration PROCEDURE

Closed Syringe Harvesting Autologous Subdermal Fat

Lipoaspiration Arm 1

AD-cSVF PROCEDURE

Use of Centricyte 1000 to isolate adipose stem/stromal cells via centrifugation

AD-cSVF Arm 2

Normal Saline IV PROCEDURE

Normal Saline IV containing AD-cSVF

Normal Saline IV Arm 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Healeon Medical Inc: lead
• Terry, Glenn C., M.D.: collaborator

Study Sites (1)

Regenevita LLC

Stevensville, Montana, 59870, United States

Location

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MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Robert W Alexander, MD

  Healeon Medical Inc

  PRINCIPAL INVESTIGATOR

• Glenn C Terry, MD

  Global Alliance for Regenerative Medicine (GARM)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: November 2, 2016
• Study Start: November 30, 2016
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)