Using Our own Stem Cells to Treat Degenerative Disc Disease

[Claire]

http://medicalxpress.com/news/2014-02-clinical-trial-stem-cell-pain.htmly

A single injection of stem cells into degenerative discs reduced low back pain for at least 12 months according to results of a 100-patient, phase II, international clinical trial that included researchers at the Emory Orthopaedics & Spine Center.

W. Jeremy Beckworth, MD, assistant professor of Orthopaedics and Rehab Medicine, was part of the trial that used injections of bone marrow stem cells called mesenchymal precursor cells (MPCs) to reduce pain. On average researchers found a pain reduction greater than 50 percent at 12 months. Additionally, there was less need for pain medication, improvement in function, and less need for further surgical and non-surgical spine interventions. These results were found in patients with moderate to severe discogenic low back pain.

"These are very exciting findings," explains Beckworth. "The results provide significant hope for a condition that has been very tough to treat. Discogenic low back pain, a painful degenerative disc, is the most common cause of chronic low back pain."

The phase II clinical trial builds on a previously reported preclinical study showing highly purified MPCs were able to repair and restore disc structure. All findings from the trial were statistically better for those receiving stem cells versus those in control.

 

[Bobcat]

Thanks Claire for this section. Can you tell me why the FDA would not give approval to stem cell therapy such as was being done by Regenerative Sciences when the doctors there have done so many treatments and have documented them and published the results? It seems to me that they should accept those studies or at least allow them as the start of whatever their long, arduous process is for getting approval. Why make it necessary to have every application approved when a doctor is just dealing with one thing such as orthopedics? I am not sure if I am making myself clear, but this whole FDA thing seems like it doesn't give Regenerative Sciences any credit for the studies already done by them.

 

[Claire]

THANK YOU, BOBCAT!

I wholeheartedly agree with you that the FDA has seriously overreached its authority into the practice of medicine with its attack against Regenerative Sciences. Here is the link to the article I wrote for a medical research journal on the topic:http://www.cellr4.org/article/401

Having been to law school, I can see how the court chose to ignore all of the other claims in the court case, however, without really taking the time to understand the real issues that were raised. Regenerative Sciences uses an antibiotic that travels in Interstate Commerce, as part of its commitment to good medical practice, to reduce swelling in a patient's injection sites; therefore, the FDA arguably has the right to regulate the end product. I do not agree with the decision, especially as the court ignored all the very valid points raised by Regenerative Sciences' lawyers.


I am a BIG supporter of Dr. Centeno's work and hope to be treated by him as soon as I can afford to do so.

Sadly, the short answer to your question is that the FDA is in bed with Pharma, and the profit is not in the cure, it's in the life long drug dependency.

 

[Donna]

Claire - This article you posted gives a link to another study. I am confused with some of these studies. I would think invasive surgery has the risk of more complications than nonsurgical treatment. Also, this study says that the authors had ties to the medical device industry and clinical decision software (not sure what that is). Then it says the results should be interpreted cautiously. Why do they even bother?


Surgery found to be marginally better for discogenic pain
(HealthDay)—Surgical patients demonstrate greater improvement at one year compared to patients utilizing nonsurgical treatment for discogenic pain, although success rates for either group are only fair, according to a study published in the November issue of The Spine Journal.


Sohail K. Mirza, M.D., M.P.H., from the Dartmouth Medical Center in Hanover, N.H., and colleagues prospectively compared outcomes of community-based surgical and nonsurgical treatments for 495 patients with chronic back pain attributed to degeneration at one or two lumbar disc levels who presented to 16 surgical offices. Surgical treatment was defined as spine surgery within six months of enrollment. Outcomes were assessed every three months.
The researchers found that 17 percent (86 patients) had surgery (instrumented fusion, 79 percent; disc replacement, 12 percent; and laminectomy or discectomy, 9 percent) within six months of enrollment. At baseline, surgical patients reported more severe pain and physical disability and were more likely to have had prior surgery. Surgery showed a limited benefit over nonsurgical treatment one year after enrollment, when using the modified (23-point) Roland disability questionnaire and adjusting for baseline group differences. When incorporating a composite score based on 30 percent improvement in the Roland score, 30 percent improvement in pain, no opioid pain medication use, and working (if relevant), the one-year success rate was 33 percent for surgery and 15 percent for nonsurgical treatment.
"The results should be interpreted cautiously because outcomes are short term and treatment was not randomly assigned," the authors write.
One author disclosed financial ties to the medical device industry; another author disclosed ties to the clinical decision software industry.

 

[Claire]

You mean the article I wrote? Or the article about DDD?

I agree with you absolutely about avoiding traditional, invasive back surgery!

 

[Donna]

I'm sorry Claire. I meant the Medical Express article.

I have read your other article in the past as well as the others that some members here wrote. Well done! Well said!

 

[Claire]

Ah! Okay. I'm just sharing info. I haven't looked at the sources. I applaud you for scrutinizing the authors/researchers for me! This is a clinical trial. Yes, most folks involved in these trials have various vested interests in its outcomes.

Neglected to say, THANK YOU for your comments on the CellR4 articles!

 

[barbara]

Seems to me that Mayo is a little behind if they are still tinkering around with rodents. Your thoughts Claire? You know much more about orthopedics than I do.


Stem cell transplant shows 'landmark' promise for treatment of degenerative disc disease

Science Daily
Date: March 8, 2014
Source: American Academy of Pain Medicine (AAPM)

Stem cell transplant was viable and effective in halting or reversing degenerative disc disease of the spine, a meta-analysis of animal studies showed, in a development expected to open up research in humans. Recent developments in stem cell research have made it possible to assess its effect on intervertebral disc (IVD) height, Mayo Clinic researchers reported in a scientific poster today at the 30th Annual Meeting of the American Academy of Pain Medicine.

"This landmark study draws the conclusion in pre-clinical animal studies that stem cell therapy for disc degenerative disease might be a potentially effective treatment for the very common condition that affects people's quality of life and productivity," said the senior author, Wenchun Qu, MD, PhD, of the Mayo Clinic in Rochester, Minn.

Dr. Qu said not only did disc height increase, but stem cell transplant also increased disc water content and improved appropriate gene expression. "These exciting developments place us in a position to prepare for translation of stem cell therapy for degenerative disc disease into clinical trials," he said.

The increase in disc height was due to restoration in the transplant group of the nucleus pulposus structure, which refers to the jelly-like substance in the disc, and an increased amount of water content, which is critical for the appropriate function of the disc as a cushion for the spinal column, the researchers concluded.

The researchers performed a literature search of MEDLINE, EMBASE and PsycINFO databases and also manually searched reference lists for original, randomized, controlled trials on animals that examined the association between IVD stem cell transplant and the change of disc height. Six studies met inclusion criteria. Differences between the studies necessitated the use of random-effects models to pool estimates of effect.

What they found was an over 23.6% increase in the disc height index in the transplant group compared with the placebo group (95% confidence interval [CI], 19.7-23.5; p < 0.001). None of the 6 studies showed a decrease of the disc height index in the transplant group. Increases in the disc height index were statistically significant in all individual studies.

The authors commented that it is time to turn attention to the much-needed work of determining the safety, feasibility, efficacy of IVD stem cell transplant for humans.

"A hallmark of IVD degenerative disease is its poor self-repair capacity secondary to the loss of IVD cells. However, current available treatments fail to address the loss of cells and cellular functions. In fact, many invasive treatments further damage the disc, causing further degeneration in the diseased level or adjacent levels," said the lead study author Jason Dauffenbach, DO. "The goal of tissue engineering using stem cells is to restore the normal function and motion of the diseased human spine."

Story Source:
The above story is based on materials provided by American Academy of Pain Medicine (AAPM). Note: Materials may be edited for content and length.

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American Academy of Pain Medicine (AAPM). "Stem cell transplant shows 'landmark' promise for treatment of degenerative disc disease." ScienceDaily. ScienceDaily, 8 March 2014. <www.sciencedaily.com/releases/2014/03/140308094811.htm>.

 

[Claire]

My heart sinks when I read yet another ortho research article on rodents or other mammals. Especially as it has already been exposed that what works for orthopedic repairs in animals does not always translate into efficacy for humans. Usually, these ortho injuries are induced by the researchers. The injuries being "fresh" means they are far more likely to respond to treatment. Stem cells are normally activated to deal with a fresh injury; this does not translate into how these treatments work on injuries that were sustained some time ago.

 

[barbara]

Thanks Claire. I knew you could give us some insight. You know how I feel about endless research on rodents as well.

 

[Claire]

Thanks Claire. I knew you could give us some insight. You know how I feel about endless research on rodents as well.

Welcome... and you and I feel the same about the ethical treatment of animals.