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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02952131




Registration number
NCT02952131
Ethics application status
Date submitted
30/10/2016
Date registered
2/11/2016

Titles & IDs
Public title
Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease
Scientific title
Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease
Secondary ID [1] 0 0
RGV-GARM3
Universal Trial Number (UTN)
Trial acronym
ADcSVF-IBD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Lipoaspiration
Treatment: Surgery - AD-cSVF
Treatment: Surgery - Normal Saline IV

Experimental: Lipoaspiration Arm 1 - Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat

Experimental: AD-cSVF Arm 2 - Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)

Experimental: Normal Saline IV Arm 3 - Normal Saline IV with AD-cSVF cells


Treatment: Surgery: Lipoaspiration
Closed Syringe Harvesting Autologous Subdermal Fat

Treatment: Surgery: AD-cSVF
Use of Centricyte 1000 to isolate adipose stem/stromal cells via centrifugation

Treatment: Surgery: Normal Saline IV
Normal Saline IV containing AD-cSVF
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Inflammatory Bowel Disease
Timepoint [1] 0 0
12 months Evaluate Function and Adverse Events
Secondary outcome [1] 0 0
Efficacy: Quality of life index , Inflammatory Bowel Disease Questionnaire(IBD-QoL)
Timepoint [1] 0 0
1 month, 6 month, 1 year
Secondary outcome [2] 0 0
Change from Baseline in C Reactive Protein (CRP)
Timepoint [2] 0 0
0, 2 weeks, 8 weeks, 12 weeks
Secondary outcome [3] 0 0
Efficacy: Change in Baseline of Modified Truelove-Witts Score (MTW)
Timepoint [3] 0 0
0, 4 weeks, 12 weeks
Secondary outcome [4] 0 0
Efficacy: Change in Baseline in Lichtiger Index
Timepoint [4] 0 0
0, 12 weeks, 6 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Montana

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Healeon Medical Inc
Address
Country
Other collaborator category [1] 0 0
Individual
Name [1] 0 0
Terry, Glenn C., M.D.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert W Alexander, MD
Address 0 0
Healeon Medical Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Walker MM, Murray JA. An update in the diagnosis o... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02952131