PHASE II PILOT PROTOCOL OF BONEMARROW STAM CELLS MOBILIZATION BY CYTOCHINE STIMULATION IN PATIENTS WITH COMPLEX ANAL FISTULAS AND/OR RECURRENCES AND/OR ANAL-PERIANAL LOCALIZATIONS OF IBD

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004590-24-IT

Enrollment

Registered

2006-06-05

Start date

2005-10-10

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PATIENTS WITH COMPLEX ANAL FISTULAS AND/OR RECURRENCES AND/OR ANAL-PERIANAL LOCALIZATIONS OF IBD MedDRA version: 6.1 Level: PT Classification code 10002644

Interventions

Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Lenograstim CAS Number: 135968-09-1 Concentration unit: µg microgram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 years and 70 Possibility to give a consent informed in absence of psychiatric pathologies of drug addiction Anal complex fistulas recurrent or plurirecurrent, transsphincteric, rounded Fistulized IBD in anal region with locoregional disease Not active suppurative processes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Renal and hepatic dysfunction 2,5 times the normal values Cardiopathy with ventricular fraction of ejection 30 or high risk of arrhythmias Positive Serology for HCV or HbsAg Allergies documented to drugs Asthma HIV Positive test of pregnancy, in the women Acute infection Neoplasia in the course of last the 5 years

Design outcomes

Primary

Measure	Time frame
Main Objective: Appraisal of the mobilization of bone marrow stem cells in patients with complex and/or recurrent anal fistulas and/or anal-perianal localizations of inflammatory bowel diseases IBD .;Secondary Objective: ;Primary end point(s): i. to verify the possibility to mobilize stem cells of bone marrow derivation, in patients with complex and/or anal recurrent fistulas and/or anal-perianal localizations of IBD; ii. to estimate if an increment in the peripheral blood of haematopoietic stem cells, can increase the possibilities of fast tissue formation of anal-perianal granulation in subject with complex and/or anal recurrent fistulas and/or anal-perianal localizations of IBD. iii. appraisal in vitro of the functionality of the stem cells and their multi differentiative ability.	—

Measure

Time frame

Main Objective: Appraisal of the mobilization of bone marrow stem cells in patients with complex and/or recurrent anal fistulas and/or anal-perianal localizations of inflammatory bowel diseases IBD .;Secondary Objective: ;Primary end point(s): i. to verify the possibility to mobilize stem cells of bone marrow derivation, in patients with complex and/or anal recurrent fistulas and/or anal-perianal localizations of IBD; ii. to estimate if an increment in the peripheral blood of haematopoietic stem cells, can increase the possibilities of fast tissue formation of anal-perianal granulation in subject with complex and/or anal recurrent fistulas and/or anal-perianal localizations of IBD. iii. appraisal in vitro of the functionality of the stem cells and their multi differentiative ability.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026