Medical Minute 6-6: Stem Cells Save Legs

By: Vanessa Welch Email
By: Vanessa Welch Email

Watching Rodney Schoenhardt work on his house, you'd never know that just a few months ago he couldn't even stand up.

"I couldn't even think about walking. I couldn't even put my foot on the ground. I was in a wheelchair," said Rodney Schoenhardt.

He had critical limb ischemia -- arterial blockages that cut off blood flow to his legs.

"Gangrene, ulcers, they can't walk, and they're facing amputation," said Gabriel Lasala, M.D., Interventional Cardiologist Med. Dir., at TCA Cellular.

"He didn't think he was going to save all my toes. He said I might even lose my foot."

For Rodney, a clinical trial at TCA Cellular Therapy changed everything. Two different kinds of stem cells were removed from his bone marrow, then processed in these incubation chambers.

"You need two types of cells. One cell that can give rise to the endothelial, that is the inner part of the blood vessel, and the other cell to take care of the outer part," said Jose Minguell, Ph.D., Scientific Director at TCA Cellular Therapy.

Once the stem cells expanded and multiplied into the millions, they were injected back into his leg.

"What we try to do with stem cells is what nature does, create new blood vessels by injecting stem cells in the area that is suffering from lack of blood flow."

Months, or even just weeks after the procedure, doctors say all 26 patients in the trial had less pain, and increased activity -- including Rodney.

"It not only saved my leg, it saved my life."

Now, with his old wheelchair collecting dust in a corner, Rodney's back on his feet-- and he couldn't be happier.

For more information on other series produced by Ivanhoe Broadcast News contact John Cherry at (407) 691-1500, jcherry@ivanhoe.com.

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MEDICAL BREAKTHROUGHS
RESEARCH SUMMARY

TOPIC: STEM CELLS SAVE LEGS
REPORT: MB #3306

BACKGROUND: According to the Mayo Clinic, peripheral artery disease (PAD) is a circulatory problem where narrowed arteries reduce blood flow to a person's limbs. When patients develop PAD, their extremities -- usually the legs -- do not receive enough blood flow to keep up with the demand. This causes leg pain when walking, which is known as intermittent claudication. PAD may also be a sign of more widespread accumulation of fatty deposits in a person's arteries, known as atherosclerosis. Patients may successfully treat PAD by stopping tobacco use, exercising and eating a healthy diet.

RISK FACTORS: Risk factors for PAD may include smoking; diabetes; obesity; high blood pressure; high cholesterol; increasing age; a family history of PAD; heart disease or stroke; and excessive levels of homocysteine, which is a protein component that helps build and maintain tissue. People who smoke or have diabetes have the highest risk of developing PAD because of reduced blood flow.

COMPLICATIONS OF PAD: If PAD is caused by atherosclerosis, patients may also be at risk for developing critical limb ischemia. This is a condition that begins with open sores that don't heal, an injury, or an infection in someone's feet or legs. Critical limb ischemia occurs when these injuries or infections progress and can cause gangrene, sometimes requiring amputation of the affected limb. These patients may also be at risk for developing stroke and heart attack.

STEM CELLS TO THE RESCUE: Now, researchers are studying whether adult stem cells could help patients with PAD. Two different kinds of stem cells are removed from the patient's bone marrow and processed in incubation chambers. Once the stem cells expand and multiply into millions, they are injected back into the patient's leg. Weeks or months after the procedure, all of the patients in a clinical trial had less pain and increased activity. This stem cell trial was designed for critical limb ischemia patients who are not candidates for surgery and have run out of options. The therapy is considered investigational.

FOR MORE INFORMATION, PLEASE CONTACT:
Chuck Naparalla
Chief Executive Officer
TCA Cellular Therapy, LLC
(985) 867-4860
cnapa@tcacellulartherapy.com

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THE FOLLOWING IS AN IN-DEPTH INTERVIEW WITH THE DOCTOR FROM THE STORY ABOVE:

Jose Minguell, Ph.D., Scientific Director at TCA Cellular Therapy, discusses how using stem cells to create new blood vessels in patients unable to walk is allowing them to get back on their feet.

Where do stem cells come from, and furthermore, how are they processed?

Dr. José Minguell: Before starting with that question, it is good to know that what we are trying to do in this clinical trial is to translate what we know from cell biology into the clinical practice. In other words, if you need to produce a new blood vessel, you may need two types of cells. One cell that can give rise to the endothelia (the inner part of the blood vessel) and the subsequent cell to take care of the outer part. In that way, you will get a new blood vessel that is working fine as well as being matured. In due course, we use two types of cells. Foremost, let’s start with the cell that gives rise to the outer part of a new endothelia, and the name of that cell is pericyte, and indeed, pericyte is a type of adult mesenchymal stem cell. In the bone marrow, we have several different types of stem cells. We have the so-called hematopoietic stem cell, the so-called mesenchymal stem cell, and the so-called endothelial stem cell. Moreover, to prepare mesenchymal stem cells, and to have a population of this cell clean (devoid of any contamination of other cells), we do what we refer to as cell expansion. The main reason of cell expansion is that the number of (we call it MSC) mesenchymal stem cells in a bone marrow aspiration is very low. When you do a bone marrow respiration, nevertheless, you never get more than 10,000. To use these cells in a clinical therapy, you need between 20 – 30 million (depending on the therapy). What we need to do is give to the cells the best conditions of culture. Then, the cells are very happy, and they start to divide, since the cells have everything that they need to grow. After approximately three weeks, we get a high number of cells in the range of 20 – 50 million, and then we have to characterize the cells in an effort to make sure that these are the cells that we need. So that is the part of the MSC (cells that form the outer part of the blood vessel). What about the inner part? For that, we do another bone marrow aspiration, and as I said before, in the bone marrow you have the hematopoietic stem cells, the MSC’s, as well as the endothelial stem cells, and these are the cells that give rise to new endothelia. With these cells, we do not need to expand them, or to clean and take out of the other cells. We use what we call mononuclear cell fraction, and that is a source of the new endothelia. Then we put both of them together (both the outer part as well as the inner), at which point we will infuse it to the patient. What we are waiting for is to see again what we know from cell biology – that if you have endothelia, then the other cells (MSC’s) will coexist outside of it (that means that you are going to have a new blood vessel).

What exactly happens inside of the body for all of this to come together? You gave us the scientific explanation, now give us the more practical description.

Dr. José Minguell: Well, you know that with ischemia patient means that the circulation of blood in the region of the limb is very poor. . . if there is any circulation at all. This is all because the patient does not have enough blood vessels. Furthermore, angiogenesis is a process that means anything can enlarge the number of blood vessels and create new blood vessels. That will contribute to the patient to have more blood cells flowing into the ischemic region. In other words, that leg will no longer be ischemic (devoid of oxygen), and the tissue will grow again.

How quickly do stem cells work inside the body?

Dr. José Minguell: Stem cells need (at least in this particular example) roughly one month. The patient receives the infusion; we follow the patient with different controls (after one week, two weeks, and four weeks of infusion). We don’t see any change, except that in four weeks' notice some change in how the patient is walking – we measure that. We change the pressure in the leg with the increase, and we continue this particular cycle for approximately six months. We then use specific instruments to observe and watch the new blood vessels.

How revolutionary is a procedure like this from a scientific standpoint?

Dr. José Minguell: I would like to say that from my point of view, the most attractive thing is that you can translate all information coming from cell biology (molecular biology), use this information in clinical studies involving animals, and then take all of the information and in due course develop a clinical trial directed to correct myriad diseases.

How exciting is this for you to see patients walking again, and to be responsible for returning these individual’s quality of life back to normal?

Dr. José Minguell: What is exceptionally exciting for me is when I see the patients coming back after one to two months of receiving the cell infusion, and they come to me and say, “Look doctor. . . I’m walking now!” Sometimes, they are so ecstatic that they cover my desk in fruits and vegetables from their gardens. Knowing that I helped these patients walk again is an unreservedly incredible feeling.

Do you think that this is just the beginning?

Dr. José Minguell: There are many diseases that thus far have no cure. I believe that in the future, cell therapy in addition to biological therapy will combine and moreover offer even more patients hope and help them stay optimistic during these difficult times in their lives.


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