Q301--Neural Stem Cell Therapy for Spinal Cord cGLP Support Intent to Sole Source

The Veteran s Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA intends to negotiate on a sole source basis with Virscio, Inc. based in New Haven, CT on behalf of the VA San Diego Healthcare System. The requirement is to provide current Good Laboratory Practice (cGLP)-compliant histopathology services supporting a nonclinical toxicology study evaluating the safety of intraspinal administration of H9 spinal cord neural stem cells (H9-scNSCs) in a cervical hemi-contusion spinal cord injury model in athymic nude rats. The services include tissue processing, paraffin embedding, histologic sectioning, hematoxylin and eosin (H&E) staining, immunohistochemistry, digital slide scanning, pathology evaluation by an American College of Veterinary Pathologists (ACVP)-board-certified veterinary pathologist, quality assurance, and preparation of a final pathology report suitable for inclusion in an FDA Investigational New Drug (IND) application
Specific Tasks and Deliverables:
1. Study Support for compliance with GLP documentation requirements SPECIFIC TASK: The Contractor shall provide scientific and administrative support necessary to execute the histopathology portion of the nonclinical safety study. Support shall include study coordination, protocol development and refinement, scheduling personnel and meetings with sponsor, sample tracking throughout each process, communication with the Sponsor, quality oversight of GLP procedures and documentation, and coordination of study activities through completion of the final report.
DELIVERABLE: Specimen inventory log including the animal number, treatment group, tissue identification, date received, received by, condition upon receipt, and storage location within 1 week or receipt of tissues.
Chain-of-custody documentation noting the transfer of specimens from one location to another within 1 week or receipt of tissue
2. Tissue Trimming received wet SPECIFIC TASK: The Contractor shall receive fixed tissues from a CRO and perform gross trimming of spinal cord, dorsal FboNotice ganglia, peripheral nervous system, and peripheral organ tissues and processed for paraffin embedding (except thoracic and lumbar pieces to be snap frozen and stored in -80C) for subsequent histologic processing.
CNS and PNS Tissue Trimming Tissue Location Number of Tissue blocks Section Orientation Analysis Spinal cord Cranial-2 Immediately Cranial to Cranial-1 (~3 mm block) 1 (30% sucrose), transfer to sponsor N/A N/A
Spinal cord Cranial-1 Immediately Cranial (~2 mm block) 1 (FFPE) Transverse H&E
Spinal cord Contusion site (~1 cm block)
1 (FFPE) Horizontal H&E, STEM121
Spinal cord Caudal-1 Immediately Caudal (~2 mm block) 1 (FFPE) Transverse H&E
Spinal cord Caudal-2 Immediately Caudal to Caudal-1 (~3 mm block) 1 (30% sucrose), transfer to sponsor N/A N/A
Spinal cord
Thoracic 1 (FFPE) Transverse H&E Spinal cord
Thoracic 3 (frozen) N/A Snap frozen Spinal cord
Lumbar 1 (FFPE) Transverse H&E Spinal cord
Lumbar 3 (frozen) N/A Snap frozen DRGs Immediately Cranial 1 (FFPE) Longitudinal N/A DRGs Contusion site 1 (FFPE) Longitudinal N/A
DRGs Immediately caudal 1 (FFPE) Longitudinal N/A Medulla Oblongata Whole 1 (FFPE) Transverse H&E *Brachial Plexus Whole 1 (FFPE) Longitudinal N/A
Total FFPE blocks = 13 Total FFPE blocks for evaluation = 9
*Brachial Plexus will be collected for the 3-month and 9-month groups. 1-month samples will be stored transferred to molecular CRO for PCR analysis.
Peripheral Organ Trimming (Group 1-6, 1 month) Tissue Number of Tissue blocks Analysis 1) Heart 1 H&E 2) Lungs with bronchii 1 H&E 3) Liver 1 H&E 4) Kidney 1 H&E 5) Spleen 1 H&E 6)Testes 1 H&E 7) Ovaries 1 H&E 8) Gross findings if present 1 H&E Total 8 paraffin blocks
Thoracic and Lumbar blocks: For all subjects (148 total). From each spinal cord level, 4 pieces of tissue will be trimmed (2-3 mm): Most rostral block will be embedded in paraffin. Other 3 blocks will be snap-frozen and stored.
Cranial-1 and caudal-1 blocks: For all subjects (148 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.
Thoracic and Lumbar blocks (snap-frozen, n=6/rat): Tissue pieces with be shipped on dry ice to molecular CRO for further analysis.
All CNS samples tissues will be dehydrated through gradient alcohols, cleared in xylene, and infiltrated with paraffin wax for subsequent embedding. Quantity: 566 tissue specimens DELIVERABLE:
Trimmed tissue specimens within 6 weeks of receipt of tissue.
Tissue preparation documentation within 6 weeks of receipt of tissue
3. Tissue Trimming received rodent brain SPECIFIC TASK: The Contractor shall perform standardized trimming of rodent brain and medulla specimens according to protocol-defined anatomical landmarks to prepare tissues for paraffin embedding and histologic evaluation.
Tissue Location Number of Tissue blocks Section Orientation Analysis Brain Whole 3 (FFPE) Standard H&E
Quantity: 150 tissue specimens
Trimmed brain specimens within 6 weeks of receipt of tissue Tissue preparation documentation within 6 weeks of receipt of tissue
4. Processing to paraffin blocks SPECIFIC TASK: The Contractor shall process protocol-specified tissues through dehydration, clearing, paraffin infiltration, embedding, and preparation of formalin-fixed paraffin-embedded (FFPE) tissue blocks while maintaining specimen identity and quality control. Quantity: 928 DELIVERABLE:
FFPE tissue blocks within 2 weeks of tissue trimming
Histology processing records within 2 weeks of tissue trimming
Quality control documentation within 2 weeks of tissue trimming
5. Unstained slides SPECIFIC TASK: The Contractor shall section FFPE tissue blocks and prepare unstained microscope slides: CNS/PNS Tissue.
Lesion Block: For all subjects (148 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 ~200 µm resulting in at least 6 representative levels through the entire dorso-ventral lesion block.
Cranial-1 and caudal-1 blocks: For all subjects (148 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.
Thoracic and Lumbar blocks: For all subjects (148 total) thoracic and lumbar blocks will be sectioned, 1 slide each.
Brain blocks: For all subjects (148 x 3 = 444 total, blocks embedded in paraffin will be sectioned, 1 slide each.
Peripheral Tissue For all subjects n=52 from the 1-month timepoint blocks embedded in paraffin will be sectioned, 1 slide each. Quantity 9912 DELIVERABLE:
Unstained tissue slides within 8 weeks of paraffin embedding Sectioning logs within 8 weeks of paraffin embedding
Slide inventory within 8 weeks of paraffin embedding
6. H&E with slide cutting scanning & pathology evaluation SPECIFIC TASK: Under GLP conditions the contractor shall perform H&E staining of specified tissue sections, and conduct microscopic evaluation by an American College of Veterinary Pathologists (ACVP) board-certified veterinary pathologist. All stains and assays will be performed according to established laboratory methods and microscopically quality checked.
Lesion block: 1 slide from each level Cranial-1 and caudal-1 blocks: 1 slide for each block Thoracic and Lumbar blocks: 1 slide for each block Brain blocks: 1 slide for each block Peripheral Tissue: For all subjects n=52 from the 1-month time point 1 slide for each block will be stained for H&E.
Quantity: 1166 DELIVERABLE:
Histopathology evaluation records withing 12 weeks of paraffin embedding
7. IHC - Manual per marker with scanning and evaluation plus SPECIFIC TASK: The Contractor shall perform manual immunohistochemical staining using protocol-specified antibodies, including the human-specific STEM121 marker, with digital slide scanning and microscopic evaluation by an ACVP board-certified veterinary pathologist. Lesion block: 1 slide from each level will be stained for human-specific STEM121.
Quantity: 900
DELIVERABLE:
Pathology evaluation records withing 12 weeks of paraffin embedding IHC quality control documentation withing 12 weeks of paraffin embedding
8. Pathology report
SPECIFIC TASK: The Contractor shall prepare a comprehensive pathology report summarizing histologic and immunohistochemical findings. The report shall include study methods, microscopic observations, representative images, interpretation of findings, and conclusions regarding the histologic safety of H9-scNSCs. The report shall be suitable for inclusion in an FDA Investigational New Drug (IND) application.
DELIVERABLE:
Draft pathology report within 8 weeks of slide evaluation Final pathology report within 4 weeks of draft report
9. Study Coordination
SPECIFIC TASK: The Contractor shall provide study coordination services throughout the study period, including schedule management, coordination with the Sponsor, monitoring of study progress, issue resolution, and preparation of routine project communications to ensure timely completion of all contract requirements.
Quantity: 16 estimated
DELIVERABLE:
Project management support throughout the study
Written project progress communications at each stage of processing
Meeting documentation including agendas, attendance and minutes withing 1 week following each meeting
6. Contractor Qualifications
The Contractor shall demonstrate the qualifications and capabilities necessary to perform GLP-compliant histology and pathology services for an FDA Investigational New Drug (IND)-supporting study involving human neural stem cell transplantation in an athymic nude rat spinal cord injury model. At a minimum, the Contractor shall meet the following requirements: Regulatory and Quality Requirements
Operate in compliance with 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies)for all activities conducted under this Statement of Work.
Maintain an independent Quality Assurance Unit (QAU) responsible for GLP inspections, critical phase audits, raw data audits, and issuance of Quality Assurance statements.
Maintain current Standard Operating Procedures (SOPs) governing tissue receipt, specimen tracking, trimming, processing, embedding, sectioning, staining, immunohistochemistry, slide review, data management, archiving, and reporting.
Maintain documented personnel training records, equipment calibration and maintenance records, and procedures supporting data integrity consistent with GLP requirements.
Maintain documented chain-of-custody procedures for all specimens from receipt through return or archival. Technical Expertise:
Histological processing of rodent central and peripheral nervous system tissues.
Histopathologic evaluation of spinal cord injury models.
Processing and evaluation of tissues from immunodeficient rodents, including athymic nude rats or equivalent models.
Histopathologic evaluation of xenogeneic or human cell transplantation studies.
Processing and evaluation of formalin-fixed paraffin-embedded (FFPE) and frozen tissue specimens.
Serial sectioning of spinal cord tissue in both transverse and horizontal orientations. Performance of hematoxylin and eosin (H&E) staining under GLP.
Performance of immunohistochemistry under GLP using human-specific antibodies, including STEM121 or an equivalent validated human-specific marker.
Identification and evaluation of donor cell engraftment, lesion morphology, inflammation, tissue repair, ectopic tissue formation, and neoplastic changes.
Demonstrated experience with histopathologic evaluation of spinal cord tissues following neural stem cell transplantation or comparable cell-based regenerative medicine approaches.
Pathology Qualifications
Histopathology evaluations shall be performed by an American College of Veterinary Pathologists (ACVP)-certified veterinary anatomic pathologist or an individual with equivalent board certification.
The evaluating pathologist shall have documented experience in rodent neuropathology, spinal cord injury pathology, and interpretation of findings associated with regenerative medicine or cellular therapy products.
The Contractor shall have the capability to evaluate:
Histopathologic changes in central and peripheral nervous system tissues; Graft survival and distribution; Evidence of donor cell persistence; Inflammatory responses; Tumorigenicity, including teratoma formation; Ectopic tissue formation; and Determination of donor versus host tissue origin using appropriate histologic and/or immunohistochemical methods.
Laboratory Capabilities:
Process, embed, section, stain, and archive all tissues specified in this Statement of Work.
Produce high-quality serial sections suitable for qualitative histopathologic evaluation.
Perform GLP-compliant immunohistochemical staining using qualified reagents and appropriate positive and negative controls.
Generate and securely maintain digital whole-slide images, when requested by the Government.
Archive slides, paraffin blocks, electronic records, raw data, and study documentation in accordance with applicable GLP requirements.
Previous Experience: The Contractor shall demonstrate prior experience performing GLP-compliant nonclinical studies in support of regulatory submissions, including experience generating pathology data suitable for FDA Investigational New Drug (IND) applications.
The Contractor shall have demonstrated expertise in the processing and evaluation of central nervous system tissues associated with spinal cord injury models, including spinal cord, brain, dorsal FboNotice ganglia, and associated peripheral tissues, using validated histopathology procedures.
The Contractor shall demonstrate prior experience conducting GLP histopathology evaluations for spinal cord neural stem cell transplantation studies or comparable regenerative medicine/cell therapy studies involving central nervous system tissues. The Contractor shall demonstrate experience processing complex spinal cord injury tissues for regulatory toxicology studies and shall possess the technical capability to evaluate tissues associated with cellular transplantation, including donor cell persistence, engraftment, distribution, inflammatory response, tissue repair, ectopic tissue formation, and potential tumorigenic changes.
The Contractor shall demonstrate experience utilizing established and validated workflows applicable to the performance of this type of nonclinical safety evaluation, including tissue processing methods, immunohistochemical assays, staining procedures, tissue orientation requirements, pathology review processes, and documentation practices necessary to generate regulatory-quality data.
The Contractor shall demonstrate experience with comparable nonclinical study methodologies and possess the capability to perform study-specific pathology evaluations, including immunohistochemical assays, tissue orientation and processing requirements, pathology evaluation, and preparation of quality documentation consistent with FDA regulatory expectations.
The Contractor shall demonstrate familiarity with the Sponsor s study design, pathology endpoints, and applicable evaluation criteria, or demonstrate equivalent experience with comparable FDA IND-supporting cellular therapy studies. The Contractor shall have the capability to produce pathology data that are scientifically comparable, consistent, and suitable for integration with previously generated nonclinical study results supporting the planned FDA IND submission.
The requirement will take place at the contractor s facility. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Monday, Sept 7, 2026, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at Michael.haydo@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.