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

NCT02952131 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-10-01

No results posted yet for this study

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

Interventions

PROCEDURE

Lipoaspiration

Closed Syringe Harvesting Autologous Subdermal Fat

PROCEDURE

AD-cSVF

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

PROCEDURE

Normal Saline IV

Normal Saline IV containing AD-cSVF

Sponsors & Collaborators

  • Terry, Glenn C., M.D.

    collaborator INDIV

  • Healeon Medical Inc

    lead INDUSTRY

Principal Investigators

  • Robert W Alexander, MD · Healeon Medical Inc

  • Glenn C Terry, MD · Global Alliance for Regenerative Medicine (GARM)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2025-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02952131 on ClinicalTrials.gov