# Human Umbilical Cord as a Regenerative Meningeal Patch to Prevent Tethering and Improve Neurological Function Following In-Utero Spina Bifida Repair

> **NIH NIH R01** · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · 2021 · $651,901

## Abstract

SUMMARY
 Over half the children who underwent in-utero spina bifida repair are unable to walk, and over one-fourth of
them require surgery for tethered spinal cord by school age. Methods to improve long-term spinal cord function
and its co-morbidities for these patients, remains elusive. The long-term goal is to find in-utero spina bifida
treatment approaches that address refinement of methodologies that will promote neurological and
neurodevelopmental gains later in life, thereby functionally adjusting patients’ quality of life for the better. The
objective of this proposal is to use a new approach to repair spina bifida in-utero in a sheep model system, which
may render more beneficial outcomes for lambs over time than current methods of repair. A cryopreserved
human umbilical cord (HUC), an allograft from a healthy term pregnancy following delivery, exerts anti-
inflammatory and anti-scarring properties, synonymously crucial processes that directly impact whether spinal
cord tethering will occur, and hence long-term outcomes. The HUC is currently FDA approved for
ophthalmological diseases. In our preclinical studies, we have shown that use of the cryopreserved human
umbilical cord as a meningeal patch helps regenerate the arachnoid layer, a key barrier to spinal cord infiltrating
scar forming cells, ultimately reducing histological tethering and improving upon spinal cord function. Our central
hypothesis is that the HUC, when used as a meningeal patch with two-layer closure during in-utero spina bifida
repair, will improve long-term clinical outcomes compared to conventional repair or predicated biomaterials. This
was formulated based on our preliminary data, representing a significant advancement in spina bifida treatment
given clinical sequelae improvements, with the potential to vertically advance in-utero treatment. The rationale
for this study is that there is an urgent critical need for an anti-scarring and regenerative matrix that can be placed
as an intermediary layer between the spinal cord and skin layer to reduce tethering. The central hypothesis will
be tested by pursuing three specific aims in a surgical spina bifida sheep model system with a myelotomy: 1) To
compare long-term functional outcome differences between in-utero SB repair methodologies using a HUC vs.
predicate (DurepairTM) biomaterial as a meningeal patch. 2) To quantify and compare long-term spatial and
temporal changes of the spinal cord at defect repair sites for tethering, syringomyelia and inflammation using 3T
MRI and diffusion tensor imaging. 3) To quantitatively compare the underlying mechanisms for long-term
therapeutic efficacies of SB defect repair methodologies. We will pursue these aims using an innovative
combination of surgical and biological manipulative techniques, since use of the cryopreserved human umbilical
cord represents a new and substantive departure from the status quo by shifting focus to the anti-inflammatory,
anti-scarring and regenerative...

## Key facts

- **NIH application ID:** 10185541
- **Project number:** 1R01HD105173-01
- **Recipient organization:** UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
- **Principal Investigator:** Ramesha Papanna
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $651,901
- **Award type:** 1
- **Project period:** 2021-04-01 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10185541

## Citation

> US National Institutes of Health, RePORTER application 10185541, Human Umbilical Cord as a Regenerative Meningeal Patch to Prevent Tethering and Improve Neurological Function Following In-Utero Spina Bifida Repair (1R01HD105173-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10185541. Licensed CC0.

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