Already revolutionizing manufacturing, 3D printing technology also promises to revolutionize the field of biotechnology. While scientists have previously had success in 3D printing a range of human stem cell cultures developed from bone marrow or skin cells, a team from Scotland's Heriot-Watt University claims to be the first to print the more delicate, yet more flexible, human embryonic stem cells (hESCs). As well as allowing the use of stem cells grown from established cell lines, the technology could enable the creation of improved human tissue models for drug testing and potentially even purpose-built replacement organs.

The scientists printed embryonic human stem cells in laboratory conditions using a new valve-based technique developed by Dr Will Wenmiao Shu and his colleagues at Heriot-Watt's Biomedical Microengineering group. The hESCs were drawn from two separate reservoirs in the printer using pneumatic pressure and deposited onto a plate in a pre-programmed, uniformed pattern through the opening and closing of a microvalve. Dr Shu says that the amount of cells dispensed can be precisely controlled by changing the nozzle diameter, the inlet air pressure and the opening time of the valve.

After the hESCs were printed, the researchers conducted tests to see if the hESCs were still alive and if they were still able to differentiate into different types of cells. The accuracy of the valve-based printing method was also assessed by examining the concentration, characterization and distribution of the printed hESCs.

We found that the valve-based printing is gentle enough to maintain high stem cell viability, accurate enough to produce spheroids of uniform size, and, most importantly, the printed hESCs maintained their pluripotency the ability to be differentiated into any other cell type, said Dr Shu. To the best of our knowledge, this is the first time that hESCs have been printed. The generation of 3D structures from hESCs will allow us to create more accurate human tissue models which are essential for in vitro drug development and toxicity-testing. Since the majority of drug discovery is targeting human disease, it makes sense to use human tissues.

The researchers believe the technology could also be used to create artificial organs and tissues that incorporate a patients own stem cells, thereby reducing the risk of the patient rejecting the organ and the need for immune suppression. This would also help address the global shortage of organ donors.

To commercialize the 3D printing technology, Dr Shus group has teamed with Scotland-based stem cell technology company Roslin Cellab. While the development of more accurate human tissue models for reliable, animal-free drug-testing is the initial goal, the longer term aim is to use the technology to create artificially created organs and tissues that incorporate a patients own stem cells. This would reduce the risk of organ rejection and the need for immune suppression and help address the global shortage of organ donors.

The team's findings are reported in the journal Biofabrication.

Source: Heriot-Watt University

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Human embryonic stem cells arranged using 3D printing technique

Fearing that unscrupulous use may hijack this promising field, stakeholders are racing to regulate its applications. Are they swift enough?

Image: Mallikarjun Katakol for Forbes India

Stempeutics Researchs CEO BN Manohar: While we work till science matures, others [stem -cells clinics] are making money from day one

We dont do clinical trials, we provide commercial stem-cell therapy, says an executive of a Pune-based company on the phone when we inquire about participating in one to avail the treatment that its website boldly speaks of. If you cant come in person, send us your case study in email and well advise you how many infusions of stem cells your patient would require, he suggests.

The companys website says it has provided 1,000 infusions to patients and is a leader in stem-cells therapy. The so-called therapy costs upwards of Rs 2-3 lakh, the executive discloses on persuasion.

This Pune clinic is only one among the many that peddle the unproven stem-cell therapy. They are supposed to enrol patients under a proper clinical trial; instead they get by with merely adding the word experimental to their offerings. You wont find these clinics on the clinical trial registry of the Indian Council of Medical Research (ICMR), where they must enlist.

Now, contrast this liberally-delivered, unregulated treatment with what Stempeutics Research in Bangalore is trying to do. For seven years, the startup, promoted by the Manipal Group and led by chief executive BN Manohar, has been at the bench studying stem cells in its labs in India and Malaysia. With a series of clinical trials, government approvals, 24 patents, 41 journal publications and Rs 125 crore in investment, the company is finally close to launching one of its threethe least regulated one at thatstem cells-based products in 2013.

These two starkly opposite sides of how this new field of regenerative medicine is developing in India point to two problems that could derail the entire thing: 1. Regulatory hurdles that hit the growth of a nascent industry: The science behind it is advancing rapidly and the medical and commercial prospects are so promising that experts fear the regulatory gaps and delays are hurting the level playing field for entrepreneurs and investors who are fleeing to countries like Malaysia and Singapore. (While it takes just 60-90 days to get regulatory clearances in Malaysia, it may take 12-18 months in India.)

Says Nitin Deshmukh, chief executive of Kotak Private Equity and an executive member of the biotech industry body, ABLE (Association of Biotechnology Led Enterprises) council: Many of our companies are shifting their research and development and IP registration to Malaysia and Singapore. They even want to license outside India. Visibly angry and disappointed, he says he has stopped investing in life sciences companies as they have no future in India. Clinical trial is the bedrock of this industry; if that is not streamlined how will companies progress?

The regulatory gaps and delays in life sciences have come to such a frustrating state that ABLE has sent a representation, rather an SOS, to the government in the new year.

The rest is here:
Stem Cells Industry: The Battle Within