A First-in-Human Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of a Novel CRISPR RNA-editing Therapy in Patients with Mecp2 Duplication Syndrome, a Rare Orphan Disease (HERO)

Recruiting N/A Interventional Study
MECP2 Duplication Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
2 – 18
Sex
Male
Study type
Interventional
Purpose
Treatment
Participants needed
6 (estimated)
Sponsor
HuidaGene Therapeutics Co., Ltd. · Industry
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About This Trial
Methyl-CpG binding protein 2 (MECP2) is a dosage-sensitive, X-linked gene critical for central nervous system development and functional maintenance, which gain-of-function causes MECP2 duplication syndrome (MDS). Affecting primarily in males, this disorder is characterized by severe intellectual disability, motor dysfunction, infantile hypotonia, epilepsy, respiratory tract infections, and premat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Males ≥ 2 and ≤18 years at the time of signing informed consent; * Genetic test and clinical confirmed diagnosis of MDS; * Stable pattern of seizures, or has had no seizures while currently receiving medical treatment (including antiepileptics) and physical therapy are stable …
Contacts

Study Director

732-318-9873

HG20401@huidagene.com

CONTACT