Early Feasibility Study: Fetoscopic NEOX Cord 1K Myelomeningocele (MMC) Repair

STATUS

Recruiting
End date

Aug 1, 2027
participants needed

15
sponsor

The University of Texas Health Science Center, Houston

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Updated on 19 February 2024

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body mass index

spina bifida

myelomeningocele

spinal cord disease

kyphosis

Summary

Show definitions

The purpose of this study is to test the feasibility of surgically covering myelomeningocele spina bifida spinal cord developmental defects using Neox Cord 1K, cryopreserved human umbilical cords, via a laparotomy-fetoscopic surgical approach. Intact repair of the defect, prevention of cerebral spinal fluid leakage and wound dehiscence will be assessed at birth and at 12 months of age.

Details

Condition	Spina Bifida, Meningomyelocele, Fetus Risk
Age	18years - 100years
Treatment	NEOX Cord 1K applied fetoscopically
Clinical Study Identifier	NCT04243889
Sponsor	The University of Texas Health Science Center, Houston
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Maternal inclusion criteria
	Singleton pregnancy
	Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 23 to 25 6/7 weeks
	Maternal age: 18 years and older
	Body mass index < 40 kg/m2
	No preterm birth risk factors (short cervix, history of previous preterm delivery)
	No previous uterine incision in the active uterine segment
	Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful
	Fetal inclusion criteria
	Spina bifida defect between T1 to S1 vertebral levels
	Myelomeningocele spina bifida 4 cm in width of the sac
	Hindbrain herniation (HH)
	No evidence of kyphosis (curved spine)
	No major life-threatening fetal anomaly unrelated to spina bifida
	Normal karyotype
Exclusion Criteria
	Maternal exclusion criteria
	Non-resident of the United States
	Multifetal pregnancy
	Insulin-dependent pregestational diabetes
	Poorly controlled A2DM insulin-dependent diabetes
	Current or planned cerclage or documented history of an incompetent cervix
	Placenta previa or placental abruption
	Short cervix of < 20 mm
	Obesity as defined by a body mass index of > 40 kg/m2
	Previous spontaneous singleton delivery prior to 37 weeks
	Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia
	HIV or Hepatitis-B positive status
	Known Hepatitis-C positivity
	Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality
	Other medical conditions which are contraindication to surgery or general anesthesia
	Patient does not have a support person
	Inability to comply with the travel and follow-up requirements of the trial
	Patient does not meet psychosocial standardized assessment criteria
	Participation in this or another intervention study that influences maternal and fetal morbidity and mortality
	Maternal hypertension
	Zika virus positivity
	Allergy/history of drug reaction to Amphotericin B
	Fetal exclusion criteria
	Major fetal anomaly not related to spina bifida
	Kyphosis in the fetus of 30 degrees or more

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Early Feasibility Study: Fetoscopic NEOX Cord 1K Myelomeningocele (MMC) Repair