Inflammatory Bowel DiseasesPhase 1/2ADcSVF-IBDNCT02952131
Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease
A Phase 1/2 study testing Lipoaspiration, AD-cSVF and Normal Saline IV in people with Inflammatory Bowel Diseases, run by Healeon Medical Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Lipoaspiration, AD-cSVF and Normal Saline IV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2016to 30 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Lipoaspiration, AD-cSVF, Normal Saline IV
- Keywords
- IBD,Crohn's,Ulcerative Bowel; Diverticulitis;IBS;UC
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoaspirationProcedure or surgery
Closed Syringe Harvesting Autologous Subdermal Fat
AD-cSVFProcedure or surgery
Use of Centricyte 1000 to isolate adipose stem/stromal cells via centrifugation
Normal Saline IVProcedure or surgery
Normal Saline IV containing AD-cSVF
| Study group | Role | What they receive |
|---|---|---|
| Lipoaspiration Arm 1 | Experimental | Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat Receives: Procedure: Lipoaspiration |
| AD-cSVF Arm 2 | Experimental | Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF) Receives: Procedure: AD-cSVF |
| Normal Saline IV Arm 3 | Experimental | Normal Saline IV with AD-cSVF cells Receives: Procedure: Normal Saline IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months Evaluate Function and Adverse Events
Secondary outcomes (4)
Efficacy: Quality of life index , Inflammatory Bowel Disease Questionnaire(IBD-QoL)
Comparison of response if it improves at least 30%
Measured: 1 month, 6 month, 1 year
Change from Baseline in C Reactive Protein (CRP)
Blood draw and laboratory measure of CRP as reflection of inflammatory baseline change
Measured: 0, 2 weeks, 8 weeks, 12 weeks
Efficacy: Change in Baseline of Modified Truelove-Witts Score (MTW)
Remission is considered if below 11, and response if it diminishes at least 30%
Measured: 0, 4 weeks, 12 weeks
Efficacy: Change in Baseline in Lichtiger Index
Remission considered if reaching 0 point, and response if the score diminishes from pretreatment level
Measured: 0, 12 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start30 Nov 2016
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Why it stopped: COVID prevented continuation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healeon Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Terry, Glenn C., M.D.
- Responsible party
- Principal investigator, Robert W. Alexander, MD, FICS, Healeon Medical Inc
- Investigators
- Robert W Alexander, MD, Principal investigator, Healeon Medical IncGlenn C Terry, MD, Study director, Global Alliance for Regenerative Medicine (GARM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952131
- Sponsor's protocol ID
- RGV-GARM3
- Acronym
- ADcSVF-IBD
- Status last verified
- Sep 2024
- First submitted
- 30 Oct 2016
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.
PubMed 17499605Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007 May 12;369(9573):1641-57. doi: 10.1016/S0140-6736(07)60751-X.
PubMed 17499606Bennike T, Birkelund S, Stensballe A, Andersen V. Biomarkers in inflammatory bowel diseases: current status and proteomics identification strategies. World J Gastroenterol. 2014 Mar 28;20(12):3231-44. doi: 10.3748/wjg.v20.i12.3231.
PubMed 24696607Wang GF, Ren JA, Liu S, Chen J, Gu GS, Wang XB, Fan CG, Li JS. Clinical characteristics of non-perianal fistulating Crohn's disease in China: a single-center experience of 184 cases. Chin Med J (Engl). 2012 Jul;125(14):2405-10.
PubMed 22882911Mahadeva U, Martin JP, Patel NK, Price AB. Granulomatous ulcerative colitis: a re-appraisal of the mucosal granuloma in the distinction of Crohn's disease from ulcerative colitis. Histopathology. 2002 Jul;41(1):50-5. doi: 10.1046/j.1365-2559.2002.01416.x.
PubMed 12121237Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e.
PubMed 23041678Maloy KJ, Powrie F. Intestinal homeostasis and its breakdown in inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):298-306. doi: 10.1038/nature10208.
PubMed 21677746Cario E. Toll-like receptors in inflammatory bowel diseases: a decade later. Inflamm Bowel Dis. 2010 Sep;16(9):1583-97. doi: 10.1002/ibd.21282.
PubMed 20803699Coskun M. Intestinal epithelium in inflammatory bowel disease. Front Med (Lausanne). 2014 Aug 25;1:24. doi: 10.3389/fmed.2014.00024. eCollection 2014.
PubMed 25593900Feller M, Huwiler K, Schoepfer A, Shang A, Furrer H, Egger M. Long-term antibiotic treatment for Crohn's disease: systematic review and meta-analysis of placebo-controlled trials. Clin Infect Dis. 2010 Feb 15;50(4):473-80. doi: 10.1086/649923.
PubMed 20067425Mowat C, Cole A, Windsor A, Ahmad T, Arnott I, Driscoll R, Mitton S, Orchard T, Rutter M, Younge L, Lees C, Ho GT, Satsangi J, Bloom S; IBD Section of the British Society of Gastroenterology. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011 May;60(5):571-607. doi: 10.1136/gut.2010.224154.
PubMed 21464096Charlebois A, Rosenfeld G, Bressler B. The Impact of Dietary Interventions on the Symptoms of Inflammatory Bowel Disease: A Systematic Review. Crit Rev Food Sci Nutr. 2016 Jun 10;56(8):1370-8. doi: 10.1080/10408398.2012.760515.
PubMed 25569442Colman RJ, Rubin DT. Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and meta-analysis. J Crohns Colitis. 2014 Dec;8(12):1569-81. doi: 10.1016/j.crohns.2014.08.006. Epub 2014 Sep 13.
PubMed 25223604Gilardi D, Fiorino G, Genua M, Allocca M, Danese S. Complementary and alternative medicine in inflammatory bowel diseases: what is the future in the field of herbal medicine? Expert Rev Gastroenterol Hepatol. 2014 Sep;8(7):835-46. doi: 10.1586/17474124.2014.917954. Epub 2014 May 12.
PubMed 24813226Langhorst J, Wulfert H, Lauche R, Klose P, Cramer H, Dobos GJ, Korzenik J. Systematic review of complementary and alternative medicine treatments in inflammatory bowel diseases. J Crohns Colitis. 2015 Jan;9(1):86-106. doi: 10.1093/ecco-jcc/jju007. Epub 2014 Nov 28.
PubMed 25518050
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02952131
- Acronym / sponsor ID
- ADcSVF-IBD / RGV-GARM3
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD,Crohn's,Ulcerative Bowel; Diverticulitis;IBS;UC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID prevented continuation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Healeon Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Terry, Glenn C., M.D.
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lipoaspiration Arm 1 | Experimental | Procedure: LipoaspirationAcquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat |
| AD-cSVF Arm 2 | Experimental | Procedure: AD-cSVFIsolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF) |
| Normal Saline IV Arm 3 | Experimental | Procedure: Normal Saline IVNormal Saline IV with AD-cSVF cells |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipoaspirationClosed Syringe Harvesting Autologous Subdermal Fat | Procedure or surgery | Lipoaspiration Arm 1 |
| AD-cSVFUse of Centricyte 1000 to isolate adipose stem/stromal cells via centrifugation | Procedure or surgery | AD-cSVF Arm 2 |
| Normal Saline IVNormal Saline IV containing AD-cSVF | Procedure or surgery | Normal Saline IV Arm 3 |
Primary outcome
Safety: Inflammatory Bowel Disease
Time frame: 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
4 secondary outcomes
Efficacy: Quality of life index , Inflammatory Bowel Disease Questionnaire(IBD-QoL)
Time frame: 1 month, 6 month, 1 year
Change from Baseline in C Reactive Protein (CRP)
Time frame: 0, 2 weeks, 8 weeks, 12 weeks
Efficacy: Change in Baseline of Modified Truelove-Witts Score (MTW)
Time frame: 0, 4 weeks, 12 weeks
Efficacy: Change in Baseline in Lichtiger Index
Time frame: 0, 12 weeks, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 17499605Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.
- Background: PubMed 17499606Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007 May 12;369(9573):1641-57. doi: 10.1016/S0140-6736(07)60751-X.
- Background: PubMed 24696607Bennike T, Birkelund S, Stensballe A, Andersen V. Biomarkers in inflammatory bowel diseases: current status and proteomics identification strategies. World J Gastroenterol. 2014 Mar 28;20(12):3231-44. doi: 10.3748/wjg.v20.i12.3231.
- Background: PubMed 22882911Wang GF, Ren JA, Liu S, Chen J, Gu GS, Wang XB, Fan CG, Li JS. Clinical characteristics of non-perianal fistulating Crohn's disease in China: a single-center experience of 184 cases. Chin Med J (Engl). 2012 Jul;125(14):2405-10.
- Background: PubMed 12121237Mahadeva U, Martin JP, Patel NK, Price AB. Granulomatous ulcerative colitis: a re-appraisal of the mucosal granuloma in the distinction of Crohn's disease from ulcerative colitis. Histopathology. 2002 Jul;41(1):50-5. doi: 10.1046/j.1365-2559.2002.01416.x.
- Background: PubMed 23041678Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e.
- Background: PubMed 21677746Maloy KJ, Powrie F. Intestinal homeostasis and its breakdown in inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):298-306. doi: 10.1038/nature10208.
- Background: PubMed 20803699Cario E. Toll-like receptors in inflammatory bowel diseases: a decade later. Inflamm Bowel Dis. 2010 Sep;16(9):1583-97. doi: 10.1002/ibd.21282.
- Background: PubMed 25593900Coskun M. Intestinal epithelium in inflammatory bowel disease. Front Med (Lausanne). 2014 Aug 25;1:24. doi: 10.3389/fmed.2014.00024. eCollection 2014.
- Background: PubMed 20067425Feller M, Huwiler K, Schoepfer A, Shang A, Furrer H, Egger M. Long-term antibiotic treatment for Crohn's disease: systematic review and meta-analysis of placebo-controlled trials. Clin Infect Dis. 2010 Feb 15;50(4):473-80. doi: 10.1086/649923.
- Background: PubMed 21464096Mowat C, Cole A, Windsor A, Ahmad T, Arnott I, Driscoll R, Mitton S, Orchard T, Rutter M, Younge L, Lees C, Ho GT, Satsangi J, Bloom S; IBD Section of the British Society of Gastroenterology. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011 May;60(5):571-607. doi: 10.1136/gut.2010.224154.
- Background: PubMed 25569442Charlebois A, Rosenfeld G, Bressler B. The Impact of Dietary Interventions on the Symptoms of Inflammatory Bowel Disease: A Systematic Review. Crit Rev Food Sci Nutr. 2016 Jun 10;56(8):1370-8. doi: 10.1080/10408398.2012.760515.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Alexander, MD principal investigator
Healeon Medical Inc
Glenn C Terry, MD study director
Global Alliance for Regenerative Medicine (GARM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lipoaspiration, AD-cSVF and Normal Saline IV in people with Inflammatory Bowel Diseases, run by Healeon Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Inflammatory Bowel Disease (time frame: 12 months Evaluate Function and Adverse Events). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02952131, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.