Histocell

The Histocell team, composed of highly qualified scientific and technical professionals, works under the highest quality standards, following GMP and ISO 13485 guidelines.

1. CELL THERAPY
Cell Therapy and Biological Medicinal Products

Human medicinal products based on cells.

Human medicinal products based on cell-secreted substances.

Cell Therapy Programs

– Stem cells
Most basal mesenchymal stem cells die immediately after transplantation, limiting their therapeutic potential.

– Oxidative stress
During the acute phase of disease, tissue is exposed to a highly damaging environment, with persistent oxidative stress and pathological inflammation.

INNOVATIVE CELL THERAPY PLATFORM
HC016 Cells
PATENTED INNOVATION

A new technology based on allogeneic adult mesenchymal stem cells designed for oxidative stress–mediated pathologies.

Cells obtained from adipose tissue through a patented Histocell process.

Higher survival and bioactivity than basal mesenchymal cells in oxidative and inflammatory environments, resulting in proven increases in therapeutic efficacy.

Indications

Conditions associated with a highly oxidative microenvironment are particularly well suited for HC016 cells.

Treatment of diseases with a significant inflammatory component.

RATIONALE

Potentiated therapeutic effect of mesenchymal stem cells (HC016), enhancing anti-inflammatory and antioxidant responses.

HC016 is designed to act in pro-inflammatory environments and aims to protect the host’s damaged tissues.

HC016 cells activate self-defense pathways against oxidative stress and inflammatory conditions.

CELL THERAPY
Therapeutic Programs Based on ASC Cells

– HC016 Spinal Cord
Treatment for acute spinal cord injury. Adipose tissue-derived mesenchymal stem cells patented by Histocell. Phase I–IIa completed with 20 treated patients.

– HC016 Lung Disease
Treatment for acute respiratory distress syndrome (ARDS). Adipose-derived mesenchymal stem cells patented by Histocell. Phase I–IIa completed with 26 treated patients.

– Bonecure
Bone regeneration in non-union fractures, infections, resections, trauma. Pre-differentiated ASCs. Phase IIa completed with 12 patients with highly positive safety and efficacy outcomes.

2. CDMO
CONTRACT MANUFACTURING – Your CDMO Partner

Histocell is a biopharmaceutical company specialized in regenerative medicine with CDMO capabilities and extensive experience in the development and manufacturing of cell-based therapies and innovative medical devices.

The facilities used for CDMO clinical-phase activities are located in the Basque Country, one of the most advanced biosanitary ecosystems.

Together with the Basque Health Cluster, Histocell is part of an innovative manufacturing hub for ATMPs based on cell and gene therapies.

- Cell Therapy Medicinal Products
What do we manufacture?

Autologous and allogeneic mesenchymal stem cells (MSC).

Other cell types: epithelial cells, chondrocytes, blood cells…

Induced pluripotent stem cells (iPSC).

Cell banks and stocks.

Sterile products.

Secretomes from different cell types.

Exosomes (R&D).

CAR-T and NK cells (R&D).

More than 13 years working in close collaboration with AEMPS (EMA).

Facilities

Authorized pharmaceutical laboratory (MIA: 4269E).

Facilities for manufacturing cell therapy products or derivatives such as secretomes.

Designed to support development, preclinical, and clinical stages, and prepared for commercial-scale manufacturing.

Fully equipped rooms for manufacturing, control, and release of autologous and allogeneic therapies.

GMP manufacturing suites for scaling up autologous therapies (simultaneous processing rooms) and allogeneic therapies (large cell banks and stocks), with associated infrastructure.

Quality services and procedures for clinical-grade material manufacturing.

Services

Process development and optimization.

Analytical method development and validation.

Scaling of autologous and allogeneic processes.

Manufacturing of intermediate and final clinical-grade products.

Cell bank (stock) manufacturing.

Fill & Finish.

Quality control and release.

Storage and cryopreservation.

3. WOUND CARE
- Reoxcare Line

Reoxcare is a line of medical devices for damaged skin and wound healing.
Reoxcare products promote the natural skin repair process.
All Reoxcare products are formulated with natural-origin ingredients.

- Reoxcare Antioxidant Dressing

A differentiated dressing for the inflammatory phase of wound healing of various etiologies.
Indicated for both chronic wounds and acute wounds in patients at risk of chronicity.

- Reoxcare Gel

New hydrogel with natural-origin ingredients for treating damaged skin and wounds of various etiologies.

4. DERMOCOSMETICS
Active Ingredients, Medical Devices, and Cosmetic Products

Development and manufacturing of effective natural-origin products for dermocosmetic skin and hair treatments.

Histocell is an ideal partner for open innovation in dermocosmetics.

Experts in biotechnologies focused on regeneration and oxidative stress control applied to dermocosmetics.

OUR KNOW-HOW — Biotechnologies

Histocell owns two patented technologies:

HISTOESSENCE TECHNOLOGY

A technology based on an exclusive natural mixture of sulfated glycosaminoglycans (chondroitin sulfate, heparan sulfate, keratan sulfate, and dermatan sulfate) and polydisperse hyaluronic acid.

What do these components provide?

Recreates and regenerates the extracellular matrix.

Induces collagen and fibronectin synthesis.

Promotes cell migration.

Histoessence mimics the extracellular matrix.

Industrial self-controlled purification process that provides extracellular matrix at different purities for a family of products (cosmetics – class III medical devices).

REOXCARE TECHNOLOGY

A technology based on an exclusive mixture of natural antioxidant active ingredients.

What do these components provide?

LBG (galactomannan): derived from carob seed flour. Traditionally used as an antioxidant and anti-inflammatory soothing ingredient.

Ascorbic acid: essential micronutrient for wound healing. Induces collagen synthesis and strengthens new tissue.

Alpha-tocopherol: natural antioxidant that reduces ROS formation and protects cell membranes.

Lycopene: carotene that neutralizes oxidative stress–related ROS. Blocks the oxidative cascade.

Turmeric: source of vitamins and minerals. Prevents oxidation and provides defense against inflammatory environments.

Prevents and protects cellular components from free-radical-induced damage, boosting intracellular defense mechanisms.
Significantly reduces intracellular ROS levels.

MARKETED PRODUCTS
Dermocosmetic Products
- Histoessence Booster

Histoessence Booster is a serum based on Native Whartonide, a biotechnological active combining hyaluronic acid and sulfated glycosaminoglycans that promotes extracellular matrix regeneration and protection against oxidative agents.

Active Ingredients
- Wharton Gel Complex

Cosmetic ingredient for dermocosmetics based on Histoessence technology.

- Reoxderm Liquid

Protects against oxidative stress induced by aesthetic treatments.
Cosmetic ingredient based on Reoxcare technology.

- Reoxderm Cleanse

Anti-acne | Antioxidant
Dermocosmetic ingredient based on Reoxcare technology.

Medical Devices
Histoessence Injectable

Sterile injectable solution for mesotherapy, based on Histoessence technology.
Natural glycosaminoglycans (15 mg/ml).

RESEARCH SERVICES FOR INNOVATIVE PRODUCTS
In Vitro Assays
Cell Types and Models

Fibroblasts, keratinocytes, mesenchymal stem cells

Oxidative stress model

Senescence model

UV radiation exposure model

In Vitro Testing

Cell viability and behavior

Protein immunolocalization

Mitochondrial activity

Chemotactic effect

Antioxidant capacity and intracellular ROS detection

Gene expression

Metalloproteinase secretion

Antimicrobial and antibiofilm effects

DEVELOPMENT & MANUFACTURING OF PROFESSIONAL AND HOME-CARE PRODUCTS
Contract Manufacturing

Cosmetic solutions for professional topical use: dermapen, microneedling, etc.

Sterile medical devices for injectable use: mesotherapy, biorevitalization, etc.

Authorized 600 m² manufacturing facilities for dermocosmetic and medical device products.

Production capacity ranging from pilot batches to large industrial batches.

5. R&D

Histocell’s R&D Department focuses on the development of new methods and technologies applied to regenerative medicine, using adult mesenchymal stem cells (AMSCs) and bioactive materials (scaffolds). Histocell R&D participates in several research programs on bone regeneration, advanced wound healing, inflammatory diseases, neuroregeneration, ischemia, lung therapy, and more.

Since its founding in 2006, Histocell has been strongly committed to R&D and now has extensive experience in R&D project development, with more than 40 national R&D projects and 9 projects under the European Framework Program for Research and Innovation (FPVII, Horizon 2020, and Horizon Europe). Histocell supports European collaborative projects to expand technical knowledge and capabilities. In the last 3 years, it has submitted more than 20 proposals and aims to participate in new projects under the current Horizon Europe program (2021–2027).

Histocell’s R&D projects have received funding from:

Government of Spain: Ministry of Science and Innovation

Basque Government: Department of Industry, Tourism and Trade

Provincial Council of Bizkaia: Department of Economic Promotion

CDTI – Centre for Industrial Technological Development

European Commission

European Regional Development Fund (ERDF)

WORKING TO IMPROVE PEOPLE'S QUALITY OF LIFE

Histocell is a regenerative medicine biopharmaceutical company that develops and manufactures cell therapy and biological products and innovative medical devices.

Own products and services, and third-party manufacturing (CDMO).