36C26226Q0655.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

Department of Veterans Affairs NCO 22 - Network Contracting 4135 S. Power Road Mesa AZ 85212

POINT OF CONTACT*

Contract Specialist Jessica Brooks jessica.brooks3@va.gov 480-466-7940

PLACE OF PERFORMANCE

VA San Diego Healthcare System

3350 La Jolla Village Drive

San Diego CA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

SPINAL PRIMATE STUDY

This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this sources sought must be in writing. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

The San Diego VA Health Care System located at 3350 La Jolla Village Drive, San Diego, CA 92161 is seeking a potential qualified contractor that can provide SPINAL PRIMATE STUDY.

Important information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The VA is mandated by Public Law 109-461 to consider a total set-aside for Service-Disabled Veteran Owned Small Business set aside. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 541380 ($19 Million Dollars).

Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov and complete Online Representations and Certifications Application (ORCA). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Dynamic Small Business Search located at https://dsbs.sba.gov/.

All interested Offerors should submit information by e-mail: by e-mail to jessica.brooks3@va.gov.

All information submissions to be marked Attn: Jessica Brooks, Contract Specialist and should be received no later than 16:00 MST on April 23, 2026.

STATEMENT OF WORK

1. Contract Title. Evaluation of the safety of intraparenchymal spinal administration of H9-scNSC in a cervical hemicontusion spinal cord injury model in nonhuman primates (NHPs)

2. Background.

We propose to advance a clinical program of neural stem cell therapy for spinal cord injury (SCI) to an IND submission and clinical trial. Our work to date has demonstrated that Neural Progenitor Cells (NPCs) and Neural Stem Cells (NSCs) survive grafting to the spinal cord and extend very large numbers of axons over long distances through the lesioned rodent and large animal spinal cord. Host axons also regenerate into cell grafts occupying the lesion site and form new synaptic connections that act as neural relays across the injury to support functional improvement in both rodents and large animals. We have identified a lead candidate human NSC/NPC line for clinical translation: an H9 human embryonic stem cell (a federally approved human cell line) that is driven to a spinal cord NSC/NPC fate. We refer to these cells as H9-scNSCs. H9-scNSCs survive grafting to cervical spinal cord hemisection and contusion lesions. This promising line of work is advancing on a translational path, supported extensively by the VA’s 1IU1RX005349-0, Neural Stem Cells for Spinal Cord Injury: Studies leading to an IND. We aim to bring this work to the point of readiness for human clinical trials in SCI. The goal of this contract is to advance this program to submission of an FDA IND, with the eventual goal of a human clinical trial of this promising approach. H9-scNSCs have been generated in compliance with Good Manufacturing Practices (GMP) and have been grafted into sites of spinal cord injury in NHPs at a CRO to ensure Good Laboratory Practice (GLP) compliance. This contract will support collection and analysis of histological safety/tox data according to current Good Laboratory Practice (cGLP) guidelines per 21 CFR Part 58 in support of our IND submission. This contract will NOT support in-life studies of NHPs, only post-mortem analysis.

3. Scope.

Regulatory compliance This GLP study will be conducted in compliance with facility SOPs and 21 CFR Part 58

Source ☒ Study tissues Non-study tissues collected for method development; see sample collection plan Other:

Preparation Trimming and Processing: The tissues will be trimmed and processed as per protocol. Of note, the spinal cord will remain in place in the spinal column and exposed to formalin through removal of the spinal column spines. The spinal cord will be trimmed at Science Park.

Tissue Blocking: tissues from both 3 months and 9 months cohorts will be processed and evaluated as per protocol and per contracting organization’s SOPs.

The spinal cord contusion block will be trimmed per Image 1.

Image 1: Contusion Dissection

Note: 3mm blocks IMMEDIATELY rostral and caudal to injury will be post fix for 24hrs and then transferred to 30% sucrose and send to sponsor Brain: The brain and medulla oblongata will be trimmed per the V01932 protocol

Sectioning CNS Tissue Sectioning:

Lesion Block (3 months and 9 months cohorts): For all subjects and both cohorts (26 total), the lesion block will be sectioned in the horizontal plane. 12 serial sections (1 slide each) will be obtained at each level separated by ~600 µm resulting in at least 6 representative levels through the entire dorso-ventral lesion block.

Cranial and caudal blocks (3 months cohort ONLY): For the 3-month timepoint subjects (11 total), the cranial and caudal transverse blocks embedded in paraffin will be sectioned in the transverse plane. 12 serial sections (1 slide each) will be sectioned and the remaining block stored.

Brain and medulla oblongata blocks (3 months ONLY): For the 3-month timepoint subjects (15 total), blocks embedded in paraffin will be sectioned. Thin sections will be obtained for H&E histology and thick sections may be obtained for DNA extraction and molecular analysis using PCR probes specific for human sequences (human Alu repeats or equivalent).

Systemic Tissue Sectioning:

For 3-month cohort only tissues (10 total) indicated for histological/microscopic analysis in the study protocol will be sectioned, 1 slide each. All 9-month cohort tissues will be held in block for possible future analysis.

Table 1: Systemic tissue sectioning – 3-month cohort

blocks

embedded in paraffin

Skeletal muscle, biceps

Any gross findings

Staining CNS Tissue staining:

Lesion block (from both 3 and 9 month cohorts): 1 slide from each level will be stained for H&E and 1 slide from each level will be stained human-specific STEM121. Labeling will be performed under 21 CFR Part 58.

Cranial and caudal blocks ( from both 3 and 9 month cohorts ): 1 slide for each block will be stained for H&E and 1 slide from each level will be stained human-specific STEM121. Labeling will be performed under 21 CFR Part 58.

All stains and assays will be performed according to established laboratory methods and microscopically quality checked.

Peripheral Tissue staining:

For 3-month cohort tissues from Table 1 will be stained with H&E.

Microscopy Digital Imaging: The slides will be evaluated on glass slides because this is a GLP study. In addition, for reference, digital whole slide images of will be generated using a 3DHistech P150 digital slide scanner for the following tissues: contusion site (H&E and STEM121: 12 slides/animal), spinal cord cranial and rostral to the concussion site (2 slides/animal), and other tissues as deemed appropriate by the pathologist.

Slides will be scanned using the 20x objective and quality checked to ensure complete image capture and lack of significant scanning artifacts. Images will be uploaded to a secure cloud-based image management system. The sponsor may be given access to all digital whole slide images upon request.

Analysis Histopathologic Analysis: An ACVP-certified Anatomic Veterinary Pathologist will microscopically evaluate stained slides.

Reporting: a formal pathology report will be produced, along with the data in Provantis. Images: A slide deck may be generated to illustrate salient findings, which will be shared with the sponsor. Specific requests for annotated images may be made for an additional charge.

4. Performance Monitoring.

Dr. Mark Tuszynski, Principal-Investigator, will monitor the performance of the contracting organization in performing post-mortem tissue analsyis during these non-clinical IND-enabling studies. He will evaluate the accuracy and provide feedback to the contracting organization.

5. Security Requirements. N/A

6. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

None

7. Other Pertinent Information or Special Considerations. No sensitive and/or proprietary information is used with this equipment.

a. Identification of Possible Follow-on Work. N/A

b. Identification of Potential Conflicts of Interest (COI). N/A

c. Identification of Non-Disclosure Requirements. N/A Contractors must execute non-disclosure agreements when they work with sensitive and/or proprietary information.

8. Place of Performance. 3350 La Jolla Village Drive, Main Hospital, San Diego, CA 92161

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