If you’re a hematologist or oncologist and need to transplant cells in your patients to keep them alive, you may need a service for graft processing that your hospital can’t provide often. Of course, some hospitals have so-called “bone marrow processing lab”, with some devices that allow to deplete red blood cells and platelets. But what if you need to customize your graft or create a new one, playing with different cell populations in sterile clinical-grade conditions?

I’d like to overview some companies which provide service for cell therapy - cell processing and manufacturing. They are not selling cell products, but they are providing a service.

These companies can provide you with solutions to start up your business in regenerative medicine, develop your own unique cell product and bring it from bench to market.

All of the companies are USA-based and use a set of standards - GMP/GTP/GLP.

let’s look what kind of services you can get today:

Cognate Bioservices Inc

Company provides number of services:

- cGMP manufacturing
- preclinical and clinical product development expertise
- cell product assay development (in vitro and in vivo tests and analysis of quality of the product)
- stem cell services - customized Production of: Human mesenchymal stem cells derived from adipose tissue, Human mesenchymal stromal / stem cells derived from bone marrow, Adipose-derived stem cells, bone marrow stromal cells, and fibroblast control cells from a variety of animal species
- commercialization of cell-based products consulting -
regulatory service and support (preparing IND according FDA requirements), process development (cost-effective solution for product development and clinical phase planning)

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Autologous (patient’s own) cell therapy is a very attractive model and currently works in hematology/oncology clinics. The main challenge for this therapeutic approach is to overcome a low number of stem or progenitor cells for clinically efficacious engraftment, followed by the long-term effect. Many research groups around the world try very hard to solve this problem, applying “ex vivo expansion” techniques.

Many of them can offer expansion of bone marrow hematopoietic or stromal stem or progenitor cells 10 or 30 times or even more. But do we really need that much?

Expansion is supposed to be clinically-graded, that is safe. Unfortunately a few reports suggest that ex vivo expansion of adult stem cells from rodent or human can lead to spontaneous malignant transformation.

For instance, this phenomenon was described for rat neuronal stem cells, mouse and human mesenchymal stromal progenitor cells. Nevertheless it still remains controversial, because other groups didn’t get any transformation during ex vivo expansion.

Recent study, published in Experimental Hematology add more oil in the fire. Authors show that endothelial progenitor cells (EPC), derived from human cord blood, undergo spontaneous transformation in culture even at earlier passages.
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Oh god, we got a new stem cell scandal yesterday - this time, in the adult stem cell field.

In 2002, a high-profile paper from Catherine Verfaillie’s group, based at the University of Minnesota was published in Nature journal. The impact of this study on the public and scientific communities was tremendous, because authors claimed that they isolate adult bone marrow stem cells with embryonic stem cell properties. They were able to maintain this “cell line” more than one year without malignant transformation. These magic cells were called “MAPC“. After that, a few more papers came up from this group, describing a similar population in detail in human and rodent bone marrow.

Other researchers were not able to reproduce this magic and by some reasons New Scientist magazine began investigation of papers and figures about MAPC came up from the group. The magazine’s reporter raised some concerns according to pictures and methods of MAPC isolation, as described in a few papers. New Scientist called Minnesota University and Nature to solve those issues.

I won’t get into all the details of the findings from this investigation, which forced Verfaillie to correct and clarify some issues, I’ll just tell you the final result - one of the top discoveries in adult stem cell research is fake and was falsified.

famous picture from Nature paper: in reality none of adult bone marrow stem cells can divide like that.

Now an expert panel called in by the university to investigate has ruled that a PhD student on the team, Morayma Reyes, falsified data.

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If you’re planning to have a baby soon or ever wondering about what “stem cell business” means and how they can make money, you may have come across “cord blood banking business“.

I was not able to miss a great discussion based on an excellent review of Michael Sullivan - Banking on cord blood stem cells, published in Nature Review Cancer. I have inserted a lot of citations below to get you to the point of this discussion.

The altruistic gifting of umbilical cord blood stem cells from one’s newborn child for the benefit an anonymous individual anywhere across the world is a remarkably generous gesture. These unrelated cord blood donations are stored and curated by an international network
of 36 public non-profit umbilical cord blood banks in 23 countries, and made available to accredited stem cell transplant centers for the treatment of life-threatening diseases, including cancer, bone marrow failure syndromes and genetic metabolic disorders.

Private (or family) cord blood banks offer a service to store a newborn child’s umbilical cord blood for possible autologous or related (family) allogeneic stem cell therapy. Development of private cord blood banking has always been under discussion. Many experts indicated pros and cons of this type of “stem cell business”.
I’m going to cite rationales against private cord blood banking, indicated in Michael Sullivan’s review (.pdf):

European commission’s Group on ethics in Science and new Technologies (eGe)
report on the ethics of private umbilical cord banking:
“The legitimacy of commercial cord blood banks for autologous use should be questioned as they sell a service, which has presently, no real use regarding therapeutic options. Thus they promise more than they can deliver. The activities of such banks raise serious ethical criticisms.”

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If you already decided to go to RegenMed (Regenerative Medicine) industry but didn’t get in to yet, you should probably read this post. I’m not an expert in industry, but I’d like to share some links to resources and offer my opinion.

First of all I’d like to separate BigPharma from Biotech and from RegenMed industry, because it’s different. RegenMed and cell therapy is relatively a new field of global Health Care industry and more close to clinic, because it operates with human material (cells, tissues) for transplantation.

Ok, If you decide to get a position in one of existing companies and you don’t know anyone from them yet (networking = 0), let’s start from:

1. Job fairs
Here, I’d advise you to dig all of job fairs in top conferences of the field (such as: International Society for Stem Cell Research or International Society for Cell Therapy, World Congress on Regenerative Medicine annual meetings)

If there is no job fair, go to companies exhibition and talk to representatives, leave them your contact or CV

I wouldn’t go to job fairs in universities, because they are completely occupied by BigPharma & Biotech (they really suck academic nerd’s brains!). RegenMed companies still not that big and not many of them will be at usual job fairs in your campus.

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