Promising Results for Stem Cell Treatment of Degenerative …

By Pat Anson, PNN Editor

An Australian regenerative medicine company has released positive results from a Phase III randomized trial showing that a single injection of its proprietary stem cell product can provide long-term relief for people with chronic lower back pain caused by degenerative disc disease.

Mesoblast Limited said the results are so promising it plans to meet with the U.S. Food and Drug Administration to discuss ways to accelerate approval of the drug as a treatment that reduces the use of opioid pain medication.

The companys stem cell product -- remestemcel-L -- has been under development for several years. It uses mesenchymal precursor cells taken from the bone marrow of healthy donors to reduce inflammation by inhibiting the production of pro-inflammatory cytokines by white blood cells.

Sixty percent of the patients in the clinical trial who were injected with remestemcel-L reported minimal or no pain after 12 months. After 24 months, 54 percent reported little or no pain, with the greatest pain reduction in patients in the early stages of degenerative disc disease. Many patients also significantly reduced their use of opioids during the study period.

The durable pain reduction for at least two years from a single administration indicates that rexlemestrocel-L has the potential to change the treatment paradigm for chronic low back pain due to inflammatory disc disease, a condition that affects as many as seven million patients across the United States and Europe, and to prevent or reduce opioid use and dependence, Dr. Silviu Itescu, CEO of Mesoblast, said in a statement.

Over 400 patients were enrolled in the Phase III trial, which was conducted at 48 sites around the world, mostly in the United States. Although Mesoblast told physicians and patients not to change any medications during the trial, after 24 months there was a 40% reduction in opioid use in patients injected with rexlemestrocel-L. Those who were given a placebo saline injection increased their daily opioid consumption.

In a previous study of patients with chronic lower back pain who did not respond to conventional treatment, a single injection of remestemcel-L also reduced pain for at least two years.

The FDA has prioritized the development of new pain treatments that reduce the use of opioids. Although the agency has taken a dim view of some stem cell therapies as unproven and potentially dangerous, Mesoblast believes the FDA will be more open-minded about its rexlemestrocel-L treatment. Last year the agency approved an investigational new drug application for rexlemestrocel-L as a therapy for COVID-19.

We now have two studies that show significant pain reduction and were fully prepared to have a discussion with FDA on a path forward, said Mesoblast Chief Medical Officer Dr. Fred Grossman. Were going to get into discussions to see if theres an accelerated path. Or, if we do need to do another study, we now have a very defined patient population where we see significant pain reduction.

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Stem Cell Therapy for Heart Disease – Cleveland Clinic

Overview Stem Cell Therapy: Helping the Body Heal Itself

Stem cells are natures own transformers. When the body is injured, stem cells travel the scene of the accident. Some come from the bone marrow, a modest number of others, from the heart itself. Additionally, theyre not all the same. There, they may help heal damaged tissue. They do this by secreting local hormones to rescue damaged heart cells and occasionally turning into heart muscle cells themselves. Stem cells do a fairly good job. But they could do better for some reason, the heart stops signaling for heart cells after only a week or so after the damage has occurred, leaving the repair job mostly undone. The partially repaired tissue becomes a burden to the heart, forcing it to work harder and less efficiently, leading to heart failure.

Initial research used a patients own stem cells, derived from the bone marrow, mainly because they were readily available and had worked in animal studies. Careful study revealed only a very modest benefit, so researchers have moved on to evaluate more promising approaches, including:

No matter what you may read, stem cell therapy for damaged hearts has yet to be proven fully safe and beneficial. It is important to know that many patients are not receiving the most current and optimal therapies available for their heart failure. If you have heart failure, and wondering about treatment options, an evaluation or a second opinion at a Center of Excellence can be worthwhile.

Randomized clinical trials evaluating these different approaches typically allow enrollment of only a few patients from each hospital, and hence what may be available at the Cleveland Clinic varies from time to time.

Cleveland Clinic is a large referral center for advanced heart disease and heart failure we offer a wide range of therapies including medications, devices and surgery. Patients will be evaluated for the treatments that best address their condition. Whether patients meet the criteria for stem cell therapy or not, they will be offered the most advanced array of treatment options.

Allogenic: from one person to another (for example: organ transplant)

Autogenic: use of one's own tissue

Myoblasts: immature muscle cells, may be able to change into functioning heart muscle cells

Stem Cells: cells that have the ability to reproduce, generate new cells, and send signals to promote healing

Transgenic: Use of tissue from another species. (for example: some heart valves from porcine or bovine tissue)

Last reviewed by a Cleveland Clinic medical professional on 01/03/2019.

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Stem Cell Therapy for Heart Disease - Cleveland Clinic

Stem Cell Therapy for Stroke Recovery | University of …

This procedure uses a combination of X-rays and computer technology to produce cross-sectional images of the body both horizontally and vertically, to detect abnormalities and help identify the location or type of stroke.

MRI uses magnetic fields to detect small changes in brain tissue that help to locate and diagnose stroke.

This nuclear brain scan uses radioactive compounds injected into a vein in the arm, and a machine (similar to a Geiger counter) to create a map showing their uptake into different parts of the head, often detecting areas of decreased blood flow and tissue damage.

This special type of CT scan can look at specific blood vessels within the body.

Using MRI technology, this procedure evaluates blood flow through arteries in a noninvasive way.

This variation of MRI is used to determine the specific location of the brain where a certain function, such as speech or memory, occurs.

This procedure records the brain's continuous, electrical activity by means of electrodes attached to the scalp.

This test records the brain's electrical response to visual, auditory, and sensory stimuli.

A small microphone is placed over the carotid artery on the neck to record sounds created by blood flow as it passes through a partially blocked artery.

A special transducer is used to direct sound waves into a blood vessel to evaluate the sound of blood moving though the vessel, looking for faintness or absence of sound.

This test measures pressure on the eyes, or detects pulses in the eyes.

This test measures the amount of oxygen in the blood supply that reaches different areas of the brain.

The test involves inserting a small, thin tube (catheter) into an artery in the leg and passing it up to the blood vessels in the brain. A contrast dye is injected through the catheter and X-ray images are taken.

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Stem Cell Therapy for Stroke Recovery | University of ...