My Butt Hurts
Squeals-a-lot!
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- Aug 2, 2007
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One of my local hospitals is doing a clinical trial study for a new Crohn's medication called prochymaltm.
This was on the TV news:
Title - Treatment with PROCHYMALTM (ex vivo cultures adult human mesenchymal stem cells) intravenouus infusion in severe Chron's disease.
Description - Subjects with moderate-to-severe Chron's that has not responded adequately to steroids, immunosuppressants, or biologic therapies. Randomized to receive 4 infusions of either low or high dose of PROCHYMAL or placebo over 14 days. Multiple visits over the first 90 days to evaluate response then yearly visits.
Sponsor: Osiris Therapeutics
And this was in the newspaper a few days later:
Stem-cell treatment test gives patient new life-
Bonnie's face blushes with energy. She's smiling, driving, shoveling snow and talking about looking for a job — and that is incredibly perplexing, especially to her.
The past 33 years have been constant cycles of fevers, chills, stomachaches, insomnia, joint pain, back pain, chest pain, 15 to 18 trips to the bathroom each day with diarrhea, even one incident two years ago when she soiled her pants while walking down the street.
The embarrassing effects of Crohn's disease had made the 66-year-old grandmother leave her job as a telephone representative, kept her from visiting her nine grandchildren and in the past year had confined her to home.
She has had three operations to remove parts of her large and small intestines. She tried steroids, immunosuppressants and biologic therapy. Nothing provided any more than temporary relief.
"I was pretty much disabled," she said. "I just wanted to go and put a blanket on me."
In March, Peters became the first patient to take part in General Hospital's first clinical stem-cell trial, which is testing a drug that could revolutionize the way doctors treat the incurable disease. The hospital is one of five in the state participating in an international research project on Crohn's disease.
The condition, often difficult to treat, can inflame any part of the digestive tract from the mouth to the anus, and the stem-cell drug could prove to be the first Crohn's medication to treat the affected areas without suppressing a patient's entire immune system. Developed from mesenchymal stem cells that come from bone marrow and can produce tissue, the drug migrates to sites of inflammation.
"Kind of like magic bullets," said Dr. Kevin Casey, Bonnie's doctor and the principal investigator of General's stem-cell trial. The ability to home in on only the areas affected by Crohn's could remedy problems with traditional drugs, which have heavy side effects and can increase patients' risk of cancer. For patients like Bonnie, who have found little relief even in newer biologic therapies that aren't as damaging to the immune system, stem cells also hold hope for effective treatment.
As part of the trial, Bonnie was given four injections over two weeks, but neither she nor Casey knows whether she received a high or low dose of the stem-cell treatment or a placebo. In any case, Bonnie has been astounded at the results.
"The past (five) weeks of my life have been awesome. ... Every few days, I notice something else is better."
In the time since her treatment, Bonnie said, her all-over body pain is gone, her regular fevers of more than 100 degrees have vanished, the diarrhea has stopped. She visits her grandchildren, helps her husband paint shelves, even thinks of going back to work.
The clinicians are impressed but cautious. Bonnie is the only participant in the trial so far, and there are no guarantees that this is a miracle drug — or even that she has received stem cells at all. No one knows how long the effects will last and whether she'll receive stem cells or a placebo if she decides to have another round of injections later.
"It does seem to be too good to be true, but we're going to hang on to that," said nurse practitioner Tia DeRosa, who directs the office of clinical research.
General researchers are trying to recruit up to 14 more patients to participate in the trial. DeRosa said the drug has no known adverse side effects, but any treatment that hasn't been approved comes with the potential for complications. Researchers monitor patients immediately after they receive the injections and for about 2½ years afterward.
Sounds promising I think. Nice to know at least that new things are happening. We'll see....
This was on the TV news:
Title - Treatment with PROCHYMALTM (ex vivo cultures adult human mesenchymal stem cells) intravenouus infusion in severe Chron's disease.
Description - Subjects with moderate-to-severe Chron's that has not responded adequately to steroids, immunosuppressants, or biologic therapies. Randomized to receive 4 infusions of either low or high dose of PROCHYMAL or placebo over 14 days. Multiple visits over the first 90 days to evaluate response then yearly visits.
Sponsor: Osiris Therapeutics
And this was in the newspaper a few days later:
Stem-cell treatment test gives patient new life-
Bonnie's face blushes with energy. She's smiling, driving, shoveling snow and talking about looking for a job — and that is incredibly perplexing, especially to her.
The past 33 years have been constant cycles of fevers, chills, stomachaches, insomnia, joint pain, back pain, chest pain, 15 to 18 trips to the bathroom each day with diarrhea, even one incident two years ago when she soiled her pants while walking down the street.
The embarrassing effects of Crohn's disease had made the 66-year-old grandmother leave her job as a telephone representative, kept her from visiting her nine grandchildren and in the past year had confined her to home.
She has had three operations to remove parts of her large and small intestines. She tried steroids, immunosuppressants and biologic therapy. Nothing provided any more than temporary relief.
"I was pretty much disabled," she said. "I just wanted to go and put a blanket on me."
In March, Peters became the first patient to take part in General Hospital's first clinical stem-cell trial, which is testing a drug that could revolutionize the way doctors treat the incurable disease. The hospital is one of five in the state participating in an international research project on Crohn's disease.
The condition, often difficult to treat, can inflame any part of the digestive tract from the mouth to the anus, and the stem-cell drug could prove to be the first Crohn's medication to treat the affected areas without suppressing a patient's entire immune system. Developed from mesenchymal stem cells that come from bone marrow and can produce tissue, the drug migrates to sites of inflammation.
"Kind of like magic bullets," said Dr. Kevin Casey, Bonnie's doctor and the principal investigator of General's stem-cell trial. The ability to home in on only the areas affected by Crohn's could remedy problems with traditional drugs, which have heavy side effects and can increase patients' risk of cancer. For patients like Bonnie, who have found little relief even in newer biologic therapies that aren't as damaging to the immune system, stem cells also hold hope for effective treatment.
As part of the trial, Bonnie was given four injections over two weeks, but neither she nor Casey knows whether she received a high or low dose of the stem-cell treatment or a placebo. In any case, Bonnie has been astounded at the results.
"The past (five) weeks of my life have been awesome. ... Every few days, I notice something else is better."
In the time since her treatment, Bonnie said, her all-over body pain is gone, her regular fevers of more than 100 degrees have vanished, the diarrhea has stopped. She visits her grandchildren, helps her husband paint shelves, even thinks of going back to work.
The clinicians are impressed but cautious. Bonnie is the only participant in the trial so far, and there are no guarantees that this is a miracle drug — or even that she has received stem cells at all. No one knows how long the effects will last and whether she'll receive stem cells or a placebo if she decides to have another round of injections later.
"It does seem to be too good to be true, but we're going to hang on to that," said nurse practitioner Tia DeRosa, who directs the office of clinical research.
General researchers are trying to recruit up to 14 more patients to participate in the trial. DeRosa said the drug has no known adverse side effects, but any treatment that hasn't been approved comes with the potential for complications. Researchers monitor patients immediately after they receive the injections and for about 2½ years afterward.
Sounds promising I think. Nice to know at least that new things are happening. We'll see....
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