Stem cell researchers working in the Waisman Center must conduct their work in an entirely sterile environment, because the resulting drugs cannot be sterilized.[/media-credit]

A University of Wisconsin research facility received an $8.8 million federal grant from the National Heart, Lung and Blood Institute to perform human clinical trials with stem cell research, including a first of its kind spinal stem cell trial.

The Waisman Center will begin testing stem cell treatments on patients with spinal injuries in six months Waisman Center Senior Scientist Derek Hei said. He added this trial will be the first of its kind in the world.

This study exemplifies the ultimate primary objective of the grant — to develop treatments for prevalent diseases using stem cells.

UW professor of Oncology Peiman Hematti is currently conducting human trials on mesenchymal stem cells — stem cells taken from bone marrow — in patients who have recently had heart attacks.

Hematti said past UW clinical trials used bone marrow stem cells on patients with diabetes and patients with Graft-versus-host disease after a bone marrow transplant.

While bone marrow stem cells have been observed to be a safe and effective treatment against certain diseases, Hematti said we don’t yet know every disease they can be used to treat.

“I think these cells are very safe, so far they have not caused any major reactions in patients, but they cannot be used for every [disease],” Hematti said.

Hei echoed this statement, saying much of the grant will be going towards finding out specifically what illnesses stem cells can treat.

Previously, Hematti said studies that have been conducted were pharmaceutical sponsored trials.

He added most of these trails dealt with illnesses that would have a large market for drugs. This grant will allow researchers to study less common diseases.

“We don’t have to depend on pharmaceutical companies anymore,” Hematti said.

Both Hei and Hematti said getting stem cell drugs into a clinic for a human trial is a long and expensive process.

Unlike many other drugs, treatments made with stem cells cannot be sterilized at the end of the making process, Hei said. Because of this, stem cell drugs have to be created in an especially clean environment.

He added once the drugs are finished they are rigorously tested and if there is any sign of contamination, they must be thrown away and made all over again.

Once the drugs are made, they are first tested on animals to demonstrate the safety of the drug.

Researchers will then submit an Investigational New Drug Application to the Food and Drug Administration. If the FDA determines the drug is safe and ready for human trial, the clinical study can then begin.

Hematti said researchers must work closely with the FDA during each step of the process to make sure all regulations are being followed.

According to Hei, these regulations along with the amount of time trials and drug cultivation takes means it will be a while before stem cell drugs are a routine treatment.