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Clinical Stem Cell Services

GMP MSC production service for your clinical application

REPROCELL and our experienced partner, Histocell, can help with your next clinical MSC project

Why MSCs?

Mesenchymal Stem Cells (MSCs), also known as Mesenchymal Stromal Cells, have received a lot of interest, both as direct therapeutic agents and for their potential to differentiate into clinically relevant somatic cell types and tissues. More than 1000 clinical trials using MSCs in a wide variety of therapeutic areas have been reported.

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Use of MSCs for Clinical Projects. MSCs can be isolated from a variety of tissues, including bone marrow, adipose tissue, and cord blood or placenta. These MSCs can be purified and expanded in the laboratory to generate sufficient cells for development of a cell therapy. Expanded MSCs can be differentiated to a variety of tissues for therapeutic applications, including cartilage, muscle, and bone.

MSCs can be isolated from multiple sources and possess the ability for self-renewal and multi-lineage differentiation (above). Further, primary MSCs can migrate toward sites of injury and tumor microenvironments, making them attractive for use as a drug delivery vehicle for targeted therapies.

All factors secreted by MSCs including paracrine substances and exosomes (extracellular vesicles) can be isolated and harvested. The MSC secretome has been shown to promote immune modulation and tissue modulation during various applications in regenerative medicine therapy.

Note: we also have Research grade MSCs and products for MSC research.

Robust track-record in GMP manufacturing

Histocell is a CDMO and a clinical-stage biopharmaceutical company specializing in developing cell therapy products for regenerative medicine. Under their established and authorized GMP Advanced Therapy Medicinal Product (ATMP) manufacturing facility, they have been providing GMP manufacturing services since 2011. Around 300 patients have already been treated with ATMPs manufactured by Histocell, and more than 350 batches have been manufactured under GMP. A highly reliable and qualified scientific team with more than 20 years of experience will take care of your cell therapy needs, with a flexible and scalable manufacturing process.

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Our MSC related services

  • Isolation and expansion of autologous or allogeneic adult adipose-derived MSCs
  • Expansion of autologous and allogeneic adult bone marrow MSCs
  • Mesodermal Trilineage differentiation of MSCs (chondrocytes, osteocytes, myocytes)
  • Purification of the secretome from co-cultured cells
  • Exosome production and characterization

We provide all regulatory QC specified by the EMA or FDA, and all the required documentary support for the cells.

 

GMP facilities

Histocell owns a new Advanced Therapies GMP cell production unit with more than 600 m2 of capacity

  • GMP manufacturing suites and associate infrastructure
  • Fully equipped to manufacture autologous and allogenic therapies
  • Pilot plant: new process setting up
  • Currently designed to support pre-clinical and clinical phases
  • Setting them to support commercial manufacturing
  • Current cell therapy and large cell stocks (MCB, WCB)
  • Production of cell-derived biological drugs as secretomes and exosomes
  • Around 1200 batches/year
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We can also help with your Research MSC Project

R&D lab – GMP-like production and QC

  • Fully equipped Molecular biology and cell culture lab including
    • Cytofluorometry
    • Spectrophotometry
    • Immunohistochemistry
  • Suitable for general R&D projects
  • Provides a GMP-like tech-transfer phase
  • Uses Quality Control similar to cell therapy drugs

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Please contact us for more information