NCT02628522

Brief Summary

Investigators performed a prospective pilot study to test the feasibility and safety of autologous adipose derived regenerative cell (ADRC) transplantation in treatment of anal fissures. The study included 6 patients with chronic anal fissures with symptoms that had an average duration of 24 months. All patients were candidates for surgical treatment as all previous conservative treatments were unsuccessful. The pain level was measured using the VAS scale and was recorded before the treatment and on every consultation following the treatment. The initial hypothesis is that application of ADRCs may be an alternative to lateral sphincterotomy and a reliable procedure to avoid fecal incontinence.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

December 2, 2015

Last Update Submit

December 10, 2015

Conditions

Anal Fissure

Keywords

ADRCCelution

Outcome Measures

Primary Outcomes (1)

  • Time to complete cessation of anal pain

    33 days

Secondary Outcomes (1)

  • Time to complete epithelization

    3 months

Study Arms (1)

ADRCs therapy

EXPERIMENTAL

Infiltration with 20mL Lidocaine 2% and Epinephrine 1:100 000. Liposuction will be done from the abdomen using Tulip cannulas. Fat will be processed with Celution system. Isolated ADRCs will be administered in chronic anal fissures.

Other: ADRCs therapyDevice: CelutionDevice: Tulip cannulasOther: 20mL Lidocaine 2% and Epinephrine 1:100 000

Interventions

ADRCs therapyOTHER

Patients with chronic anal fissures will receive one treatment of local injections of fat enriched with adipose derived regenerative cells starting from December 2014.

ADRCs therapy
CelutionDEVICE

Adipose derived regenerative cell isolation

ADRCs therapy
Tulip cannulasDEVICE

Lipoaspiration

ADRCs therapy
20mL Lidocaine 2% and Epinephrine 1:100 000OTHER

Infiltration prior to liposuction

Also known as: Xylocaine 2% and adrenaline 1:100 000
ADRCs therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. doi: 10.1007/s10350-005-0052-6.

    PMID: 15933795RESULT

  • Fox A, Tietze PH, Ramakrishnan K. Anorectal conditions: anal fissure and anorectal fistula. FP Essent. 2014 Apr;419:20-7.

    PMID: 24742084RESULT

  • Ommer A, Wenger FA, Rolfs T, Walz MK. Continence disorders after anal surgery--a relevant problem? Int J Colorectal Dis. 2008 Nov;23(11):1023-31. doi: 10.1007/s00384-008-0524-y. Epub 2008 Jul 16.

    PMID: 18629515RESULT

  • Voswinkel J, Francois S, Simon JM, Benderitter M, Gorin NC, Mohty M, Fouillard L, Chapel A. Use of mesenchymal stem cells (MSC) in chronic inflammatory fistulizing and fibrotic diseases: a comprehensive review. Clin Rev Allergy Immunol. 2013 Oct;45(2):180-92. doi: 10.1007/s12016-012-8347-6.

    PMID: 23296948RESULT

  • Borowski DW, Gill TS, Agarwal AK, Bhaskar P. Autologous adipose-tissue derived regenerative cells for the treatment of complex cryptoglandular fistula-in-ano: a report of three cases. BMJ Case Rep. 2012 Nov 9;2012:bcr2012006988. doi: 10.1136/bcr-2012-006988.

    PMID: 23144344RESULT

  • Andjelkov K, Sforza M, Barisic G, Soldatovic I, Hiranyakas A, Krivokapic Z. A novel method for treatment of chronic anal fissure: adipose-derived regenerative cells - a pilot study. Colorectal Dis. 2017 Jun;19(6):570-575. doi: 10.1111/codi.13555.

    PMID: 28574663DERIVED

MeSH Terms

Conditions

Fissure in Ano

Interventions

LidocaineEpinephrine

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Katarina Andjelkov, MD, PhD

    Clinical Centre Serbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor, principal investigator

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 11, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2015

Study Completion

October 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share