Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160739
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-11-29
Brief Title:
Role of Sirolimus in Treatment of Microcystic Mixed Lymphatic and Vascular Malformations
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Role of Sirolimus in Treatment of Microcystic Mixed Lymphatic and Vascular Malformations
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lympho-vascular malformations result from errors in embryologic vasculogenesis involving capillaries veins arteries lymphatics or a combination of these Infantile haemangiomas Vascular malformations like Capillary malformations Venous malformations they increase in size and never regress on their own They are generally present at birth they enlarge in response to infection hormonal changes or trauma Lymphatic malformations can be classified into macrocystic cyst diameter 1cm microcystic cyst diameter 1 cm or mixed in macrocystic lymphatic malformations surgery and sclerotherapy are effective Surgery of microcystic lymphatic malformations remains challenging due to their infiltrative nature Sclerotherapy is often impossible As especially large microcystic and mixed malformations are still a therapeutic challenge pharmaceutical treatment as sirolimus is used in last years as main line of treatment with great efficacy
Detailed Description:
Lympho-vascular malformations result from errors in embryologic vasculogenesis involving capillaries veins arteries lymphatics or a combination of these Infantile haemangiomas Vascular malformations like Capillary malformations Venous malformations they increase in size and never regress on their own They are generally present at birth they enlarge in response to infection hormonal changes or trauma Lymphatic malformations can be classified into macrocystic cyst diameter 1cm microcystic cyst diameter 1 cm or mixed in macrocystic lymphatic malformations surgery and sclerotherapy are effective Surgery of microcystic lymphatic malformations remains challenging due to their infiltrative nature Sclerotherapy is often impossible As especially large microcystic and mixed malformations are still a therapeutic challenge pharmaceutical treatment as sirolimus is used in last years as main line of treatment with great efficacy Sirolimus is a natural macrolide isolated from a bacteria strain of the Streptomyces genus Streptomyces hygroscopicus It was initially used as an antibiotic and antifungal agent subsequent studies have revealed impressive cytostatic antiproliferative and immunosuppressive properties Sirolimus not only prevents the growth of abnormal lymphatics but also induces the partial regression of lesions without apparent effects on normal lymphatics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None