Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02948179
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2016-10-20
Brief Title:
Using Preimplantation Genetic Diagnosis in Autosomal Dominant Polycystic Kidney Disease Patients a Multicenter Clinical Trial
Sponsor:
Changlin Mei
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
Efficacy and Safety of Preimplantation Genetic Diagnosis in Blocking Pathogenic Gene Inheritance for Autosomal Dominant Polycystic Kidney Disease a Multicenter Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-01
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:
ESPERANCE
Brief Summary:
Autosomal dominant polycystic kidney disease ADPKD is the most common monogenic hereditary kidney disease in humans ADPKD may affect all the generations of the ADPKD family and the probability of ADPKD is 50 in the second generation for each gender It has been confirmed that PKD1 and PKD2 are two pathogenic genes of ADPKD Nowadays the investigators have established an effective gene detection technology platform for PKD12 gene with long fragment PCR and next generation sequencing First the investigators performed genetic testing in patients with clinically diagnosed ADPKD and strong fertility desire but afraid of hereditary risk Using Preimplantation genetic diagnosis including multiple annealing and looping-based amplification cycles amplification technique the investigators successfully screened out healthy embryos by In Vitro Fertilization Then the investigators transplanted embryos returned to the parent When the baby is born using umbilical cord blood gene detection the investigators confirmed that the neonates do not inherit genetic defects form parents The investigators have succeeded in one couple The investigators design a multicenter clinical trial to confirm those procedures efficacy and safety
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None