An Investigative Report on the Therapeutic Candidate FAB 117-HC

1. Introduction to FAB 117-HC

1.1. Overview and Initial Identification

FAB 117-HC is an investigational drug candidate that has emerged in recent research literature. However, a comprehensive review of available information reveals a complex and, at times, contradictory profile for this designation. The primary challenge in characterizing FAB 117-HC lies in its association with two distinct therapeutic modalities targeting different medical conditions.

A significant body of evidence points to FAB 117-HC as an advanced cell-based therapy primarily under investigation for the treatment of acute traumatic spinal cord injury.[1] This profile is supported by details regarding its active pharmaceutical ingredient, HC016, its originators, Ferrer Advanced Biotherapeutics and Histocell, and specific clinical trial identifiers (EudraCT 2015-005717-80 and NCT02917291).

Conversely, other sources describe FAB 117-HC, also identified by the alternative name NeuroSave, as a recombinant chimeric monoclonal antibody engineered for the treatment of acute ischemic stroke.[5] This profile outlines a mechanism involving the neutralization of human tissue factor.

The existence of these two fundamentally different therapeutic entities under the same primary designation, "FAB 117-HC," and sharing the alias "NeuroSave" [2], presents a critical discrepancy. This report will systematically delineate both profiles based on the available data, analyze these contradictions, and discuss potential interpretations, particularly concerning the "HC" suffix. The preponderance of detailed information relates to the cell therapy candidate for spinal cord injury, which will consequently receive more extensive coverage.

1.2. Significance of the "HC" Designation – Preliminary Assessment

The "HC" component of the FAB 117-HC name warrants careful consideration. While one available document details hydrocortisone-type corticosteroids (HTC) [6], there is no direct evidence within the provided research to suggest that FAB 117-HC is a hydrocortisone formulation. Instead, within the context of the spinal cord injury therapy, "HC" appears more plausibly linked to "HC016," the designated active pharmaceutical ingredient [1], and/or "Histocell," one of the originating companies.[2] The active ingredient HC016 consists of allogeneic adipose-derived adult mesenchymal stem cells that are expanded and subsequently pulsed with hydrogen peroxide (H₂O₂).[1] This suggests that "HC" is more likely an abbreviation related to the cellular component or its developer rather than hydrocortisone. This interpretation will be further explored as each profile is detailed.

1.3. Scope of the Report

This report aims to consolidate and critically analyze all available information pertaining to FAB 117-HC from the provided research materials. It will meticulously detail the distinct drug profiles associated with this name, covering their respective originators, proposed mechanisms of action, targeted therapeutic indications, and clinical development status. Given the greater volume and specificity of information available for the mesenchymal stem cell therapy candidate, this aspect will be a primary focus. The report will also endeavor to address the notable discrepancies in the drug's identity to provide the clearest possible understanding based on current evidence.

2. Profile 1: FAB 117-HC (HC016) - Mesenchymal Stem Cell Therapy for Acute Traumatic Spinal Cord Injury

The most extensively documented profile for FAB 117-HC describes it as an investigational cell therapy for acute traumatic spinal cord injury. This section details its characteristics based on the available information.

2.1. Basic Information and Identification

Primary Name: FAB 117-HC.[1]
Alternative Names: The compound is also referred to as FAB 117, FIB 117, and NeuroSave.[2] The alias "NeuroSave" is particularly noteworthy, as it also appears in connection with the monoclonal antibody profile discussed later, contributing to potential confusion.
Active Pharmaceutical Ingredient (API): The active component of this cell therapy is designated HC016.[1] HC016 is specifically defined as allogeneic adult mesenchymal stem cells derived from adipose tissue, which are expanded and subsequently "pulsed" with hydrogen peroxide (H₂O₂).[1] This H₂O₂ preconditioning is a critical step, endowing the cells with unique properties.

2.2. Originator and Developers

The development of FAB 117-HC as a cell therapy is attributed to a collaboration:

Originators: Ferrer Advanced Biotherapeutics and Histocell S.L. are named as the originators of this therapeutic candidate.[2]
Sponsor/Promoter of Clinical Trials: Ferrer Internacional S.A. is listed as the promoter and sponsor for the European Union Clinical Trials Register (EudraCT) identified trial.[1] Histocell S.L. is also documented as providing monetary and material support for this trial.[3]

Histocell's corporate focus aligns with this profile, as the company specializes in regenerative medicine, cell therapy, and the development of biological medicinal products.[8] Ferrer's activities in the United States also include a focus on neurodegenerative disorders, which is broadly consistent with neurological repair strategies.[10]

2.3. Pharmacology

2.3.1. Drug Class

FAB 117-HC, in this profile, is classified as a mesenchymal stem cell (MSC) therapy.[2] MSCs are multipotent stromal cells that can differentiate into a variety of cell types and possess immunomodulatory and regenerative properties.

2.3.2. Mechanism of Action

The proposed mechanism of action for FAB 117-HC (HC016) is primarily based on cell replacement and the paracrine effects of the administered cells, significantly enhanced by a unique preconditioning strategy.

General Mechanism: The therapy involves the administration of allogeneic MSCs, which are intended to contribute to tissue repair and functional recovery at the site of spinal cord injury.[2]
HC016 Specifics - H₂O₂ Preconditioning and Enhanced Resilience: A distinguishing feature of HC016 is its preconditioning with low concentrations of hydrogen peroxide (H₂O₂).[1] This is not a trivial step but a sophisticated bioengineering strategy designed to augment the cells' therapeutic potential by inducing adaptive responses. This preconditioning leads to:
Increased Resistance to Oxidative Stress: The H₂O₂ pre-treatment promotes faster recovery of human Adipose-derived Stem Cells (hASCs) after cryopreservation and significantly enhances their adhesion, migration, and survival capabilities when subsequently exposed to oxidative stress conditions.[12] This enhanced resilience is crucial for the survival and efficacy of transplanted cells within the hostile, oxidative microenvironment characteristic of an acute spinal cord injury.
Activation of the Nrf2 Antioxidant Pathway: Preconditioned HC016 cells exhibit a robust defense against oxidative stress mediated by the upregulation of the Nuclear factor Erythroid 2-related factor 2 (Nrf2) pathway.[12] Nrf2 is a critical transcription factor that orchestrates the cellular antioxidant response. Its activation in HC016 cells leads to the overexpression of several key downstream antioxidant enzymes when challenged with oxidative stress (0.25 mM H₂O₂):
Heme oxygenase-1 (HO-1): Expression increased by 1.3-fold compared to non-preconditioned hASCs. HO-1 degrades heme into products with antioxidant and anti-inflammatory properties.[12]
Superoxide dismutase-1 (SOD-1): Expression increased by 1.4-fold. SOD-1 neutralizes superoxide radicals.[12]
Glutathione peroxidase-1 (GPx-1): Expression increased by 1.7-fold. GPx-1 reduces hydrogen peroxide to water.[12]
Catalase (CAT): Expression increased by 1.3-fold. CAT also decomposes hydrogen peroxide.[12] This coordinated upregulation of antioxidant enzymes results in a significant reduction in intracellular Reactive Oxygen Species (ROS) levels in HC016 cells under duress.[12]
Attenuation of NF-κB Signaling and Anti-inflammatory Effects: HC016 cells demonstrate a dampened inflammatory response. This is linked to the attenuation of the Nuclear Factor-κB (NF-κB) signaling pathway, a key mediator of pro-inflammatory gene expression. Twenty-four hours after exposure to 0.25 mM H₂O₂, HC016 cells showed 1.6-fold lower NF-κB expression compared to control hASCs. This reduced NF-κB activity translates to decreased secretion of pro-inflammatory molecules [12]:
Cyclooxygenase-2 (COX-2): 1.3-fold lower expression. COX-2 is involved in prostaglandin synthesis.[12]
Interleukin-1β (IL-1β): 1.4-fold lower expression. IL-1β is a potent pro-inflammatory cytokine.[12]
Bioenergetic Adaptations for Enhanced Survival: The preconditioning also induces significant metabolic reprogramming to meet increased energy demands under stress:
Maintained ATP Production: HC016 cells sustain a higher total ATP production rate when stressed. The decrease in ATP production under oxidative stress was 9.8% in HC016 cells versus 17% in non-preconditioned hASCs.[12]
Enhanced Mitochondrial Respiration: HC016 cells exhibit significantly higher basal mitochondrial oxygen consumption (1.8-fold higher), maximal respiratory capacity (1.4-fold higher), and ATP-linked respiration compared to hASCs after H₂O₂ exposure. Mitochondrial morphology in HC016 cells under stress appears more interconnected and tubular, indicative of enhanced fusion processes to bolster ATP production. A higher mitochondrial membrane potential is also observed.[12]
Modulated Glycolytic Metabolism: HC016 cells adopt a more glycolytic phenotype following H₂O₂ exposure, characterized by higher basal and compensatory glycolysis. This is associated with the overexpression of Hypoxia-Inducible Factor 1α (HIF-1α), a key regulator of glycolytic enzymes. This shift may help reduce ROS and meet energy needs.[12]

The allogeneic nature of HC016 cells (derived from healthy donors rather than the patient) suggests an "off-the-shelf" therapeutic potential. This could circumvent the delays and logistical complexities associated with autologous cell therapies, allowing for more timely intervention in acute conditions like SCI, where the therapeutic window is often narrow.

Role of Secreted Factors (Paracrine Effects): Beyond direct cell replacement, the conditioned medium (CM) derived from HC016 cells has demonstrated protective effects in vitro on other cell types, such as human dermal fibroblasts subjected to UVB-induced stress.[13] This indicates that paracrine signaling, through the secretion of bioactive molecules, is an important component of HC016's therapeutic action. These secreted factors include:
Growth factors with mitogenic effects.
Apoptosis-inhibiting proteins (e.g., Bcl-2, survivin, Akt).
Factors that promote collagen synthesis.
Molecules that reduce the secretion of pro-inflammatory cytokines like IL-6.[13] The HC016-CM may also contain factors that influence the Nrf2 pathway in recipient cells and potentially engage the SDF-1/CXCR4 signaling axis to promote cell migration and survival in damaged tissues.[13]

2.4. Therapeutic Indication

The primary therapeutic target for FAB 117-HC (HC016) is acute traumatic spinal cord injury (SCI).[1] The therapy is aimed at patients with thoracic level (T-level) injuries (e.g., D1-D12, with specific segments like D5-D10 targeted in different phases or cohorts of the clinical trial) and is intended for administration in the acute phase immediately following the injury.[3]

2.5. Clinical Development for Spinal Cord Injury

FAB 117-HC (HC016) is currently in Phase 1/2 clinical development for acute traumatic SCI.[1] The cornerstone of this development is a clinical trial registered under EudraCT number 2015-005717-80 and ClinicalTrials.gov identifier NCT02917291.

Table 1: Summary of Clinical Trial EudraCT 2015-005717-80 / NCT02917291 for FAB 117-HC in Spinal Cord Injury

Feature	Details	Citations
Trial ID (EudraCT)	2015-005717-80	2
Trial ID (NCT)	NCT02917291	2
Full Title	"Clinical trial of phase 1/2 to evaluate the feasibility, safety, tolerability and preliminary efficacy of the administration of FAB117-HC, a drug whose active ingredient is HC016..." (EudraCT) / "Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury" (NCT)	3
Sponsor(s)	Ferrer Internacional S.A. (Promoter/Sponsor); Histocell S.L. (Monetary/Material Support)	1
Phase	Phase 1/2 (Phase 1: open-label; Phase 2: controlled, parallel, randomized, partially double-blind, open-label follow-up)	1
Status (Latest Available)	EudraCT: Ongoing (as of May 2025). NCT02917291: Study Completion July 2023 (per SciTrials.org); ibs.GRANADA site end: Sep 2021.	1
Primary Indication	Acute Traumatic Spinal Cord Injury	1
Intervention	FAB117-HC (API: HC016 - allogeneic adipose-derived MSCs pulsed with H₂O₂). Suspension for intrathecal/intra-medullary injection. Administered during emergency stabilization surgery. Comparator (Phase 2): No study treatment.	1
Target Population	Adults with acute traumatic SCI. Phase 1: Neurological level D5-D10. Phase 2: Neurological level D1-D12. SciTrials.org: T1-T12, ASIA Impairment Scale A.	3
Primary Objectives	Assess safety and tolerability of intra-medullary administration of FAB117-HC.	3
Key Timelines/Dates	EudraCT First Entered: 2016-03-09. ibs.GRANADA site: Nov 2019 - Sep 2021. SciTrials.org (NCT): Start Dec 2016, Primary Completion Sep 2021, Study Completion Jul 2023.	1
Reported Locations	Spain (including Granada)	1
Trial Results	Specific efficacy or detailed safety results from this human trial are not provided in the available documents.	14 (General/Preclinical)

The discrepancy in completion dates and status (e.g., "Ongoing" in EudraCT as of May 2025 versus a 2023 study completion on SciTrials.org) highlights the challenge of obtaining fully harmonized and up-to-date information from secondary sources. It is important to note that while the trial design and objectives are well-described, the provided documentation does not contain published clinical results detailing safety outcomes or efficacy measures from this specific human trial (EudraCT 2015-005717-80 / NCT02917291). General reviews on stem cell therapies for SCI or animal model data are available but are not direct outcomes of this particular study.[14]

2.6. Regulatory Status and Outlook

As of February 2022, Histocell had announced an intention to launch FAB 117-HC for spinal cord injuries before 2024.[2] The current status relative to this projection is not updated in the provided materials. There is no information regarding FDA or EMA approval or specific regulatory designations (e.g., Orphan Drug, Fast Track) for FAB 117-HC (HC016) for spinal cord injury within the available documents. References to "Fabhalta" [17] concern a different pharmaceutical product from Novartis and are not relevant to FAB 117-HC.

3. Profile 2: FAB 117-HC (NeuroSave) - Recombinant Chimeric Monoclonal Antibody for Acute Ischemic Stroke

An alternative, less detailed profile for FAB 117-HC emerges from a subset of the provided information, describing it as a monoclonal antibody for acute ischemic stroke.

3.1. Basic Information and Identification

Primary Name: FAB 117-HC.[5]
Alternative Name: NeuroSave.[5] This is the same alias associated with the cell therapy profile, creating a significant point of confusion.
Active Pharmaceutical Ingredient (API): Described as a recombinant chimeric monoclonal antibody.[5] Unlike the cell therapy, no specific molecular designation (analogous to HC016) is provided for this antibody.

3.2. Originator and Developers

The originators or developers of FAB 117-HC as a monoclonal antibody for stroke are not explicitly stated in the relevant documents.[5] This lack of attribution is a key missing piece of information for this profile.

3.3. Pharmacology

3.3.1. Drug Class

The drug is classified as a recombinant chimeric monoclonal antibody.[5]

3.3.2. Mechanism of Action

The proposed mechanism of action for this monoclonal antibody involves:

Targeting and binding to human tissue factor (TF).[5]
Tissue factor is a key initiator of the extrinsic coagulation cascade and also plays a role in the inflammatory response following acute ischemic stroke.
By neutralizing tissue factor, FAB 117-HC (NeuroSave), in this context, aims to mitigate the detrimental effects of both thrombosis and inflammation, thereby creating a more conducive environment for neuronal recovery and potentially reducing the overall ischemic damage.[5] This mechanism is plausible for stroke intervention, but its connection to the "FAB 117-HC" designation is less substantiated by originator or trial data in the provided materials compared to the cell therapy.

3.4. Therapeutic Indication

The targeted therapeutic indication for this monoclonal antibody is acute ischemic stroke.[5]

3.5. Clinical Development for Stroke

Overview: Research on FAB 117-HC (NeuroSave) as a stroke therapy is described as ongoing, with clinical trials designed to investigate its safety and efficacy.[5]
Clinical Trial Information: One document mentions that "several studies are currently in various stages of completion" and refers generally to clinicaltrials.gov as a source for information.[5] However, no specific EudraCT or NCT numbers for trials involving this FAB 117-HC monoclonal antibody are provided within these particular documents.
Primary Goal of Trials: The stated aim of these trials is to evaluate the capacity of this FAB 117-HC antibody to improve functional outcomes and reduce the risk of hemorrhagic transformation in patients who have suffered an acute ischemic stroke.[5]
Variants: The documents also mention related compounds or variants, such as "FAB 117" and "FIB 117," which are described as having slight modifications to the original antibody, potentially to optimize pharmacokinetic and pharmacodynamic properties. However, detailed information on these variants is limited.[5]

3.6. Regulatory Status and Outlook

No information regarding the regulatory status (such as FDA or EMA approval or special designations) for FAB 117-HC as a monoclonal antibody for stroke is available in the provided documents.

4. Analysis of Discrepancies and Interpretation of "FAB 117-HC"

The concurrent existence of two distinct therapeutic profiles under the designation FAB 117-HC necessitates a careful analysis of the discrepancies.

4.1. Juxtaposition of the Two Profiles

A direct comparison highlights the fundamental differences between the two entities identified as FAB 117-HC:

Table 2: Comparative Summary of the Two Identified Profiles of FAB 117-HC

Feature	Profile 1: Cell Therapy for Spinal Cord Injury	Profile 2: Monoclonal Antibody for Stroke
API	HC016 (Allogeneic H₂O₂-preconditioned adipose-derived MSCs) 1	Recombinant chimeric monoclonal antibody (no specific designation given) 5
Drug Class	Mesenchymal stem cell therapy 2	Recombinant chimeric monoclonal antibody 5
Mechanism of Action	Cell replacement, enhanced resilience via Nrf2/NF-κB modulation, bioenergetic adaptation, paracrine effects 2	Neutralization of human tissue factor; anti-inflammatory and anti-thrombotic effects 5
Therapeutic Indication	Acute traumatic spinal cord injury 1	Acute ischemic stroke 5
Developers/Originators	Ferrer Advanced Biotherapeutics, Histocell S.L. 2	Not explicitly stated in provided documents for this profile 5
Key Trial ID(s)	EudraCT 2015-005717-80, NCT02917291 1	Not explicitly stated; general reference to clinicaltrials.gov 5
Alternative Names	FAB 117, FIB 117, NeuroSave 2	NeuroSave 5

This side-by-side comparison underscores the core issue: "FAB 117-HC" appears to represent two vastly different investigational products.

4.2. Addressing the "HC" Suffix

The interpretation of the "HC" suffix is crucial. As discussed in Section 1.2, its most plausible connection, based on the more detailed cell therapy profile, is to HC016 (the active ingredient) and/or Histocell (one of the originators).[1] The document discussing hydrocortisone-type corticosteroids (HTC) [6] does not establish any direct link to FAB 117-HC and is likely an unrelated finding based on a coincidental acronym match. The monoclonal antibody profile for stroke does not offer an alternative explanation for the "HC" designation. Therefore, it is reasonable to conclude that the "HC" in FAB 117-HC, particularly in its more documented form, does not refer to hydrocortisone.

4.3. Potential Explanations for the Discrepancy

Several possibilities could account for this conflicting information:

Different Products, Similar Naming: It is conceivable that Ferrer and/or Histocell, or entities associated with them, are involved in the development of two distinct therapeutic products, and an unfortunate overlap or internal coding similarity has led to the "FAB 117-HC" designation being associated with both.
Data Source Error or Misattribution: The profile of FAB 117-HC as a monoclonal antibody for stroke, which is less detailed and lacks specific trial identifiers or named originators in the provided documents [5], might stem from an error in a secondary database or a misattribution of the name "FAB 117-HC" or "NeuroSave" to an otherwise unrelated investigational product. The source of this information (Ontosight.ai) would need further scrutiny.
Evolution of a Product (Highly Unlikely): A fundamental shift from a cell-based therapy to a monoclonal antibody, while retaining the same core designation, is an improbable developmental trajectory.

The weight of evidence within the provided documents strongly favors the cell therapy for spinal cord injury as the more robustly documented entity under the FAB 117-HC name. This profile is supported by multiple sources, specific clinical trial identifiers, named developers, and detailed mechanistic information for the HC016 active ingredient.

4.4. The "NeuroSave" Alias Conundrum

The use of "NeuroSave" as an alternative name for both the cell therapy [2] and the monoclonal antibody [5] is a significant complicating factor. This shared alias suggests that "NeuroSave" might be a broader project or platform name used by a developer for multiple candidates targeting neurological conditions, or it could simply be another instance of data conflation in the sources. It means that "NeuroSave" cannot be used as a unique identifier to disambiguate the two profiles based on the current information.

The existence of these conflicting profiles under the same primary identifier and shared alias underscores a critical need for careful data source verification. While this report synthesizes the information as presented, definitive clarification would necessitate consulting primary documentation from the developers, regulatory agencies, or conducting more exhaustive searches in comprehensive, curated pharmaceutical intelligence databases.

5. Conclusion and Future Perspectives

5.1. Summary of Findings

The investigation into FAB 117-HC, based on the available documentation, reveals a complex situation characterized by a dual identity:

Primarily, FAB 117-HC is identified as an investigational advanced therapy medicinal product for acute traumatic spinal cord injury. This therapy, developed by Ferrer Advanced Biotherapeutics and Histocell, utilizes HC016 as its active pharmaceutical ingredient. HC016 consists of allogeneic adipose-derived mesenchymal stem cells that undergo a unique H₂O₂ preconditioning process. This preconditioning is designed to enhance cellular resilience and therapeutic efficacy by activating the Nrf2 antioxidant pathway, modulating NF-κB inflammatory responses, and inducing favorable bioenergetic adaptations. This cell therapy candidate has been evaluated in a Phase 1/2 clinical trial (EudraCT 2015-005717-80 / NCT02917291). The "HC" in its name most plausibly refers to HC016 and/or Histocell.
Secondarily, and with significantly less substantiating detail within the provided documents, FAB 117-HC (also termed NeuroSave) is described as a recombinant chimeric monoclonal antibody. This antibody purportedly targets human tissue factor for the treatment of acute ischemic stroke, aiming to mitigate inflammation and thrombosis. However, specific developers and dedicated clinical trial identifiers for this monoclonal antibody under the FAB 117-HC name are not clearly provided in the available materials.

The alias "NeuroSave" is associated with both profiles, further complicating clear differentiation.

5.2. Emphasis on the Unresolved Discrepancy

The most significant outcome of this review is the identification of this unresolved discrepancy regarding the fundamental nature of FAB 117-HC. This report is constrained by the information contained within the provided documents. The conflicting data highlight a limitation in relying solely on aggregated or secondary sources without cross-verification against primary data from developers or regulatory bodies. Definitive clarification as to whether FAB 117-HC represents two distinct products, a data entry error in one set of sources, or another explanation is not possible from the current dataset alone. This situation may reflect the "fog of early drug development," where information can be fragmented or inconsistently reported across various platforms as research progresses.

5.3. Potential Implications and Directions

For FAB 117-HC (HC016) in Spinal Cord Injury: Should this cell therapy program progress successfully, its allogeneic "off-the-shelf" nature, combined with the sophisticated H₂O₂ preconditioning technology (HC016), could offer substantial advantages in treating acute SCI. The preconditioning strategy, aimed at enhancing cell survival and function in the harsh post-injury environment, is a notable scientific advancement. Future research directions would heavily depend on the comprehensive results from the Phase 1/2 trial, focusing on definitive efficacy in improving neurological outcomes and long-term safety. The underlying preconditioning technology itself, designed to bolster MSCs against oxidative stress, may also hold promise for other cell therapy applications beyond SCI.
For the Monoclonal Antibody Profile (NeuroSave) in Stroke: If this is a valid, distinct investigational product, further information is critically needed regarding its originators, specific clinical trial data (including identifiers, phase, and results), and overall development status to accurately assess its therapeutic potential. The proposed mechanism targeting tissue factor is scientifically relevant for stroke.
Nomenclature and Data Integrity: The confusion arising from the shared "FAB 117-HC" designation and the "NeuroSave" alias underscores the paramount importance of precise and unambiguous nomenclature in pharmaceutical development and reporting. Clear and consistent identification is vital for accurate tracking, data aggregation, and communication within the scientific and medical communities.

In conclusion, while the profile of FAB 117-HC as the HC016 cell therapy for spinal cord injury is more substantially detailed and supported by specific trial information in the provided documents, the existence of a conflicting profile necessitates caution. Further investigation using primary data sources is essential to definitively resolve the identity and status of any therapeutic candidate designated as FAB 117-HC.

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FAB 117-HC Advanced Drug Monograph

Generic Name