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Trial record 2 of 2 for:    Andjelkov

A Novel Method for Chronic Anal Fissure Treatment

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ClinicalTrials.gov Identifier: NCT02628522
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Katarina Andjelkov, Clinical Centre of Serbia

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.


Condition or disease Intervention/treatment Phase
Anal Fissure Other: ADRCs therapy Device: Celution Device: Tulip cannulas Other: 20mL Lidocaine 2% and Epinephrine 1:100 000 Not Applicable

Detailed Description:

This prospective pilot study includes 6 patients suffering from chronic anal fissure. All patients were previously treated with different local applications of glyceryl trinitrate or topical Xylocaine gel. Some patients took oral analgesics as a concomitant therapy for additional pain control. None of the patient received neither topical calcium channel blockers nor Botulinum toxin injection due to the unavailability.

The primary outcome measured is "time to complete cessation of anal pain". The secondary outcome includes the healing of chronic anal fissure defined as "time to complete epithelization".

The study was approved by the Ethics Committee of the First Surgical Clinic, Faculty of Medicine, and University of Belgrade. The study was performed in accordance with the Declaration of Helsinki and current Good Clinical Practices. All patients gave the written informed consent prior to the participation.

Physical examination and the detail medical history has been taken by an experienced colorectal surgeon. Pain assessment is quantified using the visual analog scale (VAS) before the treatment and during each postoperative outpatient visit. Bowel continence has been also assessed using Wexner fecal incontinence score prior to the treatment and during each postoperative outpatient visit. The liposuction procedure has been performed performed under the combination of local anesthesia and moderate sedation/general anesthesia. The mixture of 180 mL saline solution, 1mL Epinephrine (1:10,000) and 20 mL of 2% lidocaine is injected in the subcutaneous layer of the abdominal wall to allow the tumescence and to decrease the blood loss. The manual liposuction procedure has been carried out through two or three small incisions using Sforza harvester (Tulip® medical products, San Diego, USA). Approximately 150-200 mL of raw lipoaspirate is obtained from each patient. The harvest site is then covered with a pressure dressing for 10 days to reduce swelling and hematoma. The closed system PureGraft® 250mL (PureGraft®, Solana Beach, California, USA) has been used used to collect the specimen. The specimen is transferred within 15 min to the BelPrime Clinic laboratory where the Celution® 800/CRS system (Cytori Therapeutics, Inc. San Diego, California, USA) is applied to process the lipoaspirate in order to obtain ADRCs. The Celution® 800/CRS system is a closed automated medical device that helps to separate blood and fat. The system will then digests fat using the proprietary enzyme reagent Celase 835/CRS (Cytori Therapeutics, Inc. San Diego, California, USA) to release the stromal vascular fraction (SVF). SVF is subsequently concentrated by a short centrifugation and then automated wash cycles to obtain the ADRC fraction. This 90 to 120-minute process provides approximately 5mL of pellet. A few drops of the obtained pellet were immediately used for cell counting (ChemoMetec A/S DK-3450, Allerod, Denmark).

The second procedure has been performed in lithotomy position. Intravenous prophylactic antibiotic (1gm Metronidazol) are administered. After the careful and gentle anal examination, anal fissure is first curetted using a small size curette. The pellet is divided into two parts. The first 2mL of the pellet is mixed with 8mL of the lipid part of the lipoaspirate purified by Puregraft® 50 system. This solution (10mL) is injected subcutaneously into the edge of the fissure using the criss-cross lattice technique by Tulip® 1,2 mm injector. The rest of the pellet, (approximately 2-5mL), is infiltrated directly into the fissure base (internal anal sphincter) using a 20G needle. No laxatives or stool softener is prescribed. Patients have been discharged from the hospital a few hours after the procedure.

Patients are followed up weekly by telephone interview during the first 2 months, then monthly up to 12 months after the procedure. The outpatient visits are scheduled monthly until 9 months to ensure the healing of anal fissure. Visual analogue scale (VAS) score and Wexner fecal incontinence score [31] are also recorded.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Method for Chronic Anal Fissure Treatment: Adipose Derived Regenerative Cells - A Pilot Study
Study Start Date : December 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADRCs therapy

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

Device: Celution
Adipose derived regenerative cell isolation

Device: Tulip cannulas
Lipoaspiration

Other: 20mL Lidocaine 2% and Epinephrine 1:100 000
Infiltration prior to liposuction
Other Name: Xylocaine 2% and adrenaline 1:100 000




Primary Outcome Measures :
  1. Time to complete cessation of anal pain [ Time Frame: 33 days ]

Secondary Outcome Measures :
  1. Time to complete epithelization [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The inclusion criteria were adults (>18 years) with chronic (> 8 weeks of conservative therapy) anal fissures

Exclusion Criteria:

  • The exclusion criteria were autoimmune diseases, inflammatory bowel disease, presence of malignant or chronic infectious disease, or immunosuppressive therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628522


Sponsors and Collaborators
Clinical Centre of Serbia
Investigators
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Principal Investigator: Katarina Andjelkov, MD, PhD Clinical Centre Serbia

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Katarina Andjelkov, Clinical professor, principal investigator, Clinical Centre of Serbia
ClinicalTrials.gov Identifier: NCT02628522     History of Changes
Other Study ID Numbers: CCS-1
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Katarina Andjelkov, Clinical Centre of Serbia:
ADRC
Celution

Additional relevant MeSH terms:
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Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents