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Inflammatory Bowel Diseases

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

Sponsored by Healeon Medical Inc

About this trial

Last updated 9 months ago

Study ID

RGV-GARM3

Status

Suspended

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18 to 85 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 9 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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)

No

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

Locations

Location

Status