Myelomeningocele, Myeloschisis, Spina Bifida
Conditions
Keywords
Neox Cord 1K, Fetoscopic repair, Cryopreserved human umbilical cord
Brief summary
To fetoscopically use cryopreserved human umbilical cord allografts, named NEOX Cord 1K®, as a spinal cord cover of spina bifida defects. This procedure will be performed to create a watertight seal covering over the spinal cord in order to decrease the incidence rates of postnatal morbidities. For larger skin defects, NEOX Cord 1K® may be used as a skin cover.
Interventions
DEVICENEOX Cord 1K
Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Maternal inclusion criteria: * Singleton pregnancy * Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 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 * Chiari II malformation * No evidence of kyphosis (curved spine) * No major life-threatening fetal anomaly unrelated to spina bifida * Normal karyotype, or normal Chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance
Exclusion criteria
Maternal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pregnant Women With Successful Fetoscopic Repair of the Defect Using NEOX Cord 1K® | Immediately after repair procedure | A digital image of the fetal repair site will be captured during and immediately after the repair. The images will be sent to three independent blinded neurosurgeons for review of successful closure of the defect. More than best of three votes will be considered as the result. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Infants With Intact Repair of the Defect, Defined as no Cerebrospinal Fluid Leakage and no Dehiscence at the Repair Site. | Birth |
| Number of Infants With Intact Repair of the Defect as Defined as no Cerebrospinal Fluid Leakage and no Dehiscence at the Repair Site. | 12 months ± 2 months after birth |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRamesha Papanna, MD, MPH
The University of Texas Health Science Center, Houston
Participant flow
Pre-assignment details
50 Pregnant women were enrolled each with one fetus for a total of 100 participants enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 32 / 50 | 25 / 50 |
Outcome results
None listed