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PROSPECTIVE STUDY ?IBDISC?: Regeneration and Immunity in patients affected by IBD undergoing immunomodulatory treatment and adjuvant role of G-CSF and/or plasmapheresis (Inflammatory Bowel Diseases Immunity and Stem Cells) - IBDISC

PROSPECTIVE STUDY ?IBDISC?: Regeneration and Immunity in patients affected by IBD undergoing immunomodulatory treatment and adjuvant role of G-CSF and/or plasmapheresis (Inflammatory Bowel Diseases Immunity and Stem Cells) - IBDISC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-008285-12-IT
Enrollment
48
Registered
2009-04-14
Start date
2009-10-14
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Inflammatory bowel disease MedDRA version: 9.1 Level: PT Classification code 10011401 MedDRA version: 9.1 Level: LLT Classification code 10045282

Interventions

Trade Name: GRANOCYTE 34 Pharmaceutical Form: Solution for injection INN or Proposed INN: Lenograstim Concentration unit: µg/kg microgram(s)/kilogram Concentration type: equal Concentration number: 10

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This will be a monocentric, prospective trial, open label. 24 consecutive patients affected by crohn disease (CD) and 24 patients affected by ulcerative colitis (UC) will be enrolled. Inclusion criteria: - moderate-severe disease activity from a clinical and endscopic point of view (Mayo score >6) - estensive lesions (L2-L3 sec. Montreal) - candidate to receive a biological treatment with anti-TNFα (Infliximab - IFX - or Adalimumab ?ADA-), because of resistance, dependence or intolerance to conventional treatments, or because of the presence of fistulae (CD) resistant to common therapies. At the moment of the enrollment, patients will be required to sign a written consent. 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: - Tuberculosis or other severe infections (sepsis, etc) - moderate ? severe heart failure (Class III/IV NYHA) and/or hemodynamic instability - known ipersensitivity to the drugs (Infliximab; Adalimumab; G-CSF), to murine proteins or the any of the eccipients contained in the drugs - Kostman Syndrome (severe congenital neutropenia), myelodysplastic syndromes, chronic myeloid leucemia - Anemia and/or coagulopathies and/or anticoagulant treatments

Design outcomes

Primary

MeasureTime frame
Main Objective: - feasibility and tollerability.;Secondary Objective: nd;Primary end point(s): nd—

Countries

Italy

Outcome results

None listed

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