Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

July 22, 2003

Primary Completion Date

May 15, 2007

Study Completion Date

May 15, 2007

Conditions
Ulcerative Colitis
Interventions
DRUG

Dex 21-P

At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter.

DRUG

Placebo

Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P

Trial Locations (1)

71013

Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo

All Listed Sponsors
collaborator

Casa Sollievo della Sofferenza IRCCS

OTHER

lead

Quince Therapeutics S.p.A.

INDUSTRY

NCT01171807 - Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis | Biotech Hunter | Biotech Hunter