Published: Wednesday, 5/11/2016 - Updated: 1 day ago
ProMedica joins stem-cell research on treating traumatic brain injuries
BY MARLENE HARRIS-TAYLOR
BLADE MEDICAL EDITOR
ProMedica is partnering with a California-based stem cell company to research the benefits of stem cells in treating traumatic brain injuries. ProMedica is partnering with a California-based stem cell company to research the benefits of stem cells in treating traumatic brain injuries.
ProMedica is partnering with a California-based stem cell company to research the benefits of stem cells in treating traumatic brain injuries.
The Toledo health system is joining forces with Stemedica Cell Technologies, Inc., to create a research institute at ProMedica Toledo Hospital, which will be named in honor of hockey great Gordie Howe.
Mr. Howe’s star power is raising awareness in the United States and Canada about advances in stem-cell therapies as he continues what is being called a “miraculous” recovery from a massive stroke.
The 88-year-old former Detroit Red Wings player would likely have died if he had not traveled in 2014 to a medical clinic in Tijuana, Mexico, for an experimental stem-cell treatment not yet available in the United States, said his personal physician, Dr. Roger Kruse, who is also a sport’s medicine specialist for ProMedica.
Members of Mr. Howe’s family are expected to appear at news conference at 1:30 p.m. today at the Inverness Country Club to officially announce the Gordie Howe Initiative Scientific Advisory Board. His son, Dr. Murray Howe, is director of sports medicine imaging for Toledo Hospital.
Dr. Kruse will be the principal investigator for the initiative that will oversee a clinical trial using adult stem cells in traumatic brain injury patients. A nine-member, scientific advisory board will supervise the clinical research and helped to design the clinical trial.
The clinical trial, which is expected to begin later this year, will test whether stem cells supplied by Stemedica can regenerate brain tissue in people who have suffered injuries in car accidents, on the battlefield from bombs, or from sports, Dr. Kruse said.
The stem cells used in the clinical trial were taken from bone marrow tissue, harvested from an adult donor, and then multiplied in a lab. “With one donor you can do as many as 600,000 treatments,” he said.
Although this type of treatment is currently available in other countries, the U.S. Food and Drug Administration is requiring further proof that it is safe before authorities will approve it for use in the United States. There have been some positive results for those patients who have received the stem cells in other countries, Dr. Kruse said.
“I wouldn’t be doing this if I didn’t think it would help people. I’m not doing this just for safety,” he said.
This is the first clinical trial of this type in the U.S. and the partnership of ProMedica and Stemedica, along with the national stature of Mr. Howe, helped with the selection of Toledo as the location of this brain injury research.
Both ProMedica and Stemedica are contributing money to privately fund this research project, ProMedica officials, however, would not disclose the exact amount the company’s financial contribution to the project.
“I don't’ think anything of this magnitude has ever been done in Toledo,” said Dr. Kruse, who called it “cutting edge” research.
The clinical trial will involve 24 people who are between the ages 18 and 45 years old. To be selected, the participants must have been living with brain injuries for at least six months, but not longer than five years.
“And the can’t have really bad coexisting diseases,” he said.
FDA guidelines prohibit ProMedica from advertising or directly soliciting people for the study at this point in the process. Most of the participants will be patients of Dr. Kruse or referred to Dr. Kruse by other physicians, said Angie Link, director of research at ProMedica.
ProMedica may do some advertising later in the year if they don’t find enough eligible participants through the referral process.
“Even if we do radio ads the script has to be approved, ” Ms. Link said.
All government approved clinical trials are listed on clinicaltrials.gov and this Toledo trial will be on the website some time later this summer. Those interested in finding it can use the search function on the site and use the words Stemedica or Dr. Kruse to find it, she said.
Once up and running it is expected to last about 12 months. It is open to people from across the country but the preference is for participants who live in the region. They will have to travel to Toledo several times throughout the year and the further away people live, the less likely they are to continue to participate in the study, Dr. Kruse said.
“We are trying to figure out how much we help them. Does this have to be repeated every so often? If we get results do they stay.for long periods of time?” he said.
Depending on the preliminary results from the clinical trial there may be a need for further studies or they may find it didn't’ work on brain cell regeneration.
“If this works it will definitely bring people here for treatment. No question,” Dr. Kruse said.
ProMedica joins stem-cell research on treating traumatic brain injuries
BY MARLENE HARRIS-TAYLOR
BLADE MEDICAL EDITOR
ProMedica is partnering with a California-based stem cell company to research the benefits of stem cells in treating traumatic brain injuries. ProMedica is partnering with a California-based stem cell company to research the benefits of stem cells in treating traumatic brain injuries.
ProMedica is partnering with a California-based stem cell company to research the benefits of stem cells in treating traumatic brain injuries.
The Toledo health system is joining forces with Stemedica Cell Technologies, Inc., to create a research institute at ProMedica Toledo Hospital, which will be named in honor of hockey great Gordie Howe.
Mr. Howe’s star power is raising awareness in the United States and Canada about advances in stem-cell therapies as he continues what is being called a “miraculous” recovery from a massive stroke.
The 88-year-old former Detroit Red Wings player would likely have died if he had not traveled in 2014 to a medical clinic in Tijuana, Mexico, for an experimental stem-cell treatment not yet available in the United States, said his personal physician, Dr. Roger Kruse, who is also a sport’s medicine specialist for ProMedica.
Members of Mr. Howe’s family are expected to appear at news conference at 1:30 p.m. today at the Inverness Country Club to officially announce the Gordie Howe Initiative Scientific Advisory Board. His son, Dr. Murray Howe, is director of sports medicine imaging for Toledo Hospital.
Dr. Kruse will be the principal investigator for the initiative that will oversee a clinical trial using adult stem cells in traumatic brain injury patients. A nine-member, scientific advisory board will supervise the clinical research and helped to design the clinical trial.
The clinical trial, which is expected to begin later this year, will test whether stem cells supplied by Stemedica can regenerate brain tissue in people who have suffered injuries in car accidents, on the battlefield from bombs, or from sports, Dr. Kruse said.
The stem cells used in the clinical trial were taken from bone marrow tissue, harvested from an adult donor, and then multiplied in a lab. “With one donor you can do as many as 600,000 treatments,” he said.
Although this type of treatment is currently available in other countries, the U.S. Food and Drug Administration is requiring further proof that it is safe before authorities will approve it for use in the United States. There have been some positive results for those patients who have received the stem cells in other countries, Dr. Kruse said.
“I wouldn’t be doing this if I didn’t think it would help people. I’m not doing this just for safety,” he said.
This is the first clinical trial of this type in the U.S. and the partnership of ProMedica and Stemedica, along with the national stature of Mr. Howe, helped with the selection of Toledo as the location of this brain injury research.
Both ProMedica and Stemedica are contributing money to privately fund this research project, ProMedica officials, however, would not disclose the exact amount the company’s financial contribution to the project.
“I don't’ think anything of this magnitude has ever been done in Toledo,” said Dr. Kruse, who called it “cutting edge” research.
The clinical trial will involve 24 people who are between the ages 18 and 45 years old. To be selected, the participants must have been living with brain injuries for at least six months, but not longer than five years.
“And the can’t have really bad coexisting diseases,” he said.
FDA guidelines prohibit ProMedica from advertising or directly soliciting people for the study at this point in the process. Most of the participants will be patients of Dr. Kruse or referred to Dr. Kruse by other physicians, said Angie Link, director of research at ProMedica.
ProMedica may do some advertising later in the year if they don’t find enough eligible participants through the referral process.
“Even if we do radio ads the script has to be approved, ” Ms. Link said.
All government approved clinical trials are listed on clinicaltrials.gov and this Toledo trial will be on the website some time later this summer. Those interested in finding it can use the search function on the site and use the words Stemedica or Dr. Kruse to find it, she said.
Once up and running it is expected to last about 12 months. It is open to people from across the country but the preference is for participants who live in the region. They will have to travel to Toledo several times throughout the year and the further away people live, the less likely they are to continue to participate in the study, Dr. Kruse said.
“We are trying to figure out how much we help them. Does this have to be repeated every so often? If we get results do they stay.for long periods of time?” he said.
Depending on the preliminary results from the clinical trial there may be a need for further studies or they may find it didn't’ work on brain cell regeneration.
“If this works it will definitely bring people here for treatment. No question,” Dr. Kruse said.