Science

AUTOLOGOUS CELLULAR THERAPY

Autologous cellular therapy has recently emerged as a credible and practical treatment option for cancer and other highly debilitating diseases.
Cell-Gene company is focused on developing clinical-stage autologous cellular therapy as a potentially transformative approach to treating neurodegenerative diseases.
Cell-Gene company has developed a targeted, innovative, proprietary and validated autologous cellular technology platform (NurOwn®) for the treatment of neurodegenerative diseases.

MSC-NTF CELLS

Autologous MSC-NTF cells represent a promising therapeutic candidate by targeting disease pathways important in neurodegenerative disorders.
Autologous MSC-NTF cells are produced from the patient’s own bone marrow-derived MSCs that have been differentiated in culture.
A patient’s own MSCs are harvested and differentiated to secrete high levels of NTFs using a proprietary technology. The differentiated MSCs, known as MSC-NTF cells, are then harvested and prepared for injection into the patient. The MSC-NTF cells are not genetically modified.
Autologous MSC-NTF cells represent an innovative cellular therapy approach that can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

BEFORE DIFFERENTIATION: MSCs

AFTER DIFFERENTIATION: MSC-NTF CELLS

Source: Cell-Gene company, Data on file. Detection of GDNF expression in MSC and MSC-NTF cells by immunofluorescence.

NTF LEVELS BEFORE AND AFTER DIFFERENTATION

Autologous MSC-NTF cells secrete a unique profile of bioactive molecules, including NTFs, microRNA and cytokines

Following intrathecal administration, the autologous MSC-NTF cells may activate neuroprotective and immunomodulatory pathways

MSC-NTF CELL PRODUCTION

Cell-Gene company has pioneered production of autologous MSC-NTF cells. We have developed proprietary methods to engineer, produce, and purify autologous MSC-NTF cells at a scale and quality necessary to bring MSC-NTF therapeutics to patients with debilitating neurodegenerative diseases.
Each treatment consists of a ready-for-injection syringe containing 100-125 x 106 freshly-harvested autologous MSC-NTF cells in a volume of 4 mL. The MSC-NTF cells are autologous and therefore unlikely to induce an adverse immune response.
Cell-Gene company has entered into agreements with Dana-Farber Cancer Institute (Dana-Farber) in Boston, Massachusetts and the City of Hope National Medical Center in Duarte, California to provide clean room facilities for production of autologous MSC-NTF cells.

MSC-NTF CELL PRODUCTION

Cell-Gene company has pioneered production of autologous MSC-NTF cells. We have developed proprietary methods to engineer, produce, and purify autologous MSC-NTF cells at a scale and quality necessary to bring MSC-NTF therapeutics to patients with debilitating neurodegenerative diseases.
We hold rights to clinical development and commercialization of the NurOwn® technology platform through an exclusive, worldwide licensing agreement.

RECENT CELL-GENE COMPANY PUBLICATIONS AND PRESENTATIONS

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Here you can see some frequently asked questions or contact us!

What passage are your cells?

Our human mesenchymal stem/stromal cells (hMSCs) are provided at a population doubling level (PDL) of 8-10 post-mononuclear isolation (Bone Marrow; Equivalent Passage 2) or 14-18 post-isolation from the perivascular region of Wharton’s Jelly (Umbilical Cord; Equivalent Passage 3). Due to variabilities of seeding and harvest densities we characterize our MSC “True Age” in terms of their PDL.

How often should I feed your cells?

A: There is no need to feed cells between passages. Our media is engineered to be a batch culture media, where no media exchange or feed is necessary when following our suggested protocols.

Are your vials sold from pooled donors?

No, we do not pool donors at any time during our production. Master Cell Banks (MCBs) are created from each donor source. Working Cell Banks (WCBs) are produced from our MCBs for general product sales.

What characterization do you provide for your hMSCs?

We characterize our hMSCs by following ISCT criteria: cell identity (surface marker expression), functional potency (angiogenic cytokine and IDO secretion), and trilineage differentiation (adipo-, osteo-, and chondrogenesis). This information is provided to allow customers to choose the optimal hMSC tissue type and donor for their specific application or target indication.