By all accounts, Reed Whitener shouldn’t be here.

He was troubled with incredible pain in his back and ribs, hurting so badly that a sneeze would leave him unable to walk. His regular doctor kept trying various treatments, but a diagnosis was not forthcoming. He went to a surgeon who saw something on an X-ray but said it was caused by arthritis.

Whitener bought some over-the-counter arthritis pain medication and went home to do yardwork. “I was not going to let arthritis stop me,” he says.

But then his regular doctor, internal medicine practitioner Francesca Glynn, saw the X-ray and was concerned. She called the next day and referred him to an oncologist. When she called him “Mr. Whitener” instead of by his first name as usual, he knew it was serious.

He had a blood cancer, multiple myeloma. Whitener was stage 3 and had an aggressive form of the disease. With the diagnosis came the prognosis: He had three to five years to live. It was September 2007, and Whitener was 51. He and his wife, Ellen, had three teenagers, and he resolved to face the cancer head-on. He visited VCU Massey Cancer Center, where hematologist and oncologist Edward B. Perkins offered assurance that they would “do all we can to help you.”

The treatment plan called for culling stem cells from his bone marrow and storing them while he endured chemotherapy. The treatment kills the cancer, but it destroys other cells, too, and “brings you almost to near death,” Whitener says.

His stem cells were returned to his body after the harsh treatment, but they didn’t thrive. He needed more, and a sister proved a good match. In November 2008, he received his sibling’s stem cells, and was out of the hospital by Christmas Eve. A biopsy showed no cancer.

“I was just ecstatic,” he says.

But a life-threatening complication ensued: Whitener developed graft versus host disease (GVH), a condition in which the donated stem cells attacked his cells. He had stage 4 GVH of the gut and was advised to get his affairs in order.

The Massey team conferred with other cancer specialists and got to work, trying a variety of treatments, medication concoctions and surgery. The battle took 18 months of doubts, treatments and care, including 100 days of hospitalization, but it was well worth it.

Now, Whitener, an account manager with Southeastern Freight Lines, is working full time in sales and was able to witness the birth of his granddaughter in September. A decade on, he’s still cancer-free. “I’m very fortunate,” he says. “Whatever they did was amazing, a miracle.”

× Expand Reed Whitener and his wife, Ellen, walking their dog Dot (Photo by Ash Daniel)

An Evolving Field

Stem cell therapy is, indeed, miraculous, but it’s a mystery born of science, part of the rise of cell-based therapies or regenerative therapies that use the body’s immune system to heal itself. As with any treatment, complications can ensue, and those can be life-threatening, as Whitener’s experience illustrates.

It’s a new field that is expanding, with applications ranging from Whitener’s bone marrow transplant and newer, cutting-edge procedures in development at facilities including VCU, to outpatient procedures used to allay pain and promote healing in people with arthritis that are offered by doctors and even chiropractors.

Consider cellular therapy as a way to influence the immune system, “to use the body’s very elegant and complex defense mechanism,” says John McCarty, director of the Cellular Immunotherapies and Transplant Program at VCU Massey Cancer Center. McCarty had the privilege of declaring Whitener cancer-free.

“Stem cells carry great promise, but they also cause great issues.” —Dr. John McCarty

Use of bone marrow stem cells began in the 1980s, and stem cells started to be used from other sources such as umbilical cord blood in the 1990s. That has led to therapy in which specific cells are manipulated to “hone the tool,” McCarty says. He says cell therapy has evolved from its use as a last resort to become the standard of care for augmenting traditional therapies.

Orthopedic surgeon William E. Nordt III of OrthoVirginia is intrigued by regenerative therapy, but he maintains a healthy skepticism, too. “It’s definitely captured the imagination,” he says. “The goal in our world is regenerating normal tissue; it’s where we want to be. Stem cells are part of the answer.”

But it’s an evolving field, and regulations are only now being worked out. Nordt notes that there’s a lot of hyperbole and exaggeration about what stem cells can do. That can lead to a Wild West atmosphere, in which potential patients need to look out for themselves.

“There’s a lot of unscrupulous people out there,” Nordt says. “Anyone other than a physician injecting you with stem cells, it’s a questionable practice.”

Yet, he also notes that there’s a counter-argument to his stance. People in pain will pay and pay well to have their symptoms alleviated, even though they have to pay out of pocket, because health insurance providers don’t cover stem cell therapies.

“Everybody likes the thought of an injection over surgery,” he says. “The expectation is that they will be pain-free and cured.”

Also, stem cells are touted by some as a product to make you young again, “an injectable fountain of youth,” Nordt says, adding that some patients tune out his concerns, reasoning that this is what they’d expect an orthopedic surgeon to say — “that a surgeon would want to do surgery.”

× Expand Jill Grizzard removing cells from cryogenic storage at Massey Cancer Center (Photo courtesy John Wallace)

Hope and Help

Stories from some patients who have received the treatment are compelling.

Stem cell therapy followed surgery for a rotator cuff tear in the left shoulder for Midlothian resident Regina Knapp. Vic Goradia, an orthopedic surgeon with G2 Orthopedics and Sports Medicine in Glen Allen, performed the surgery in March, and the stem cell treatment began about five weeks later.

Knapp had done her homework, researching stem cell therapy for about a year, she says. She had been in a sedentary job for 21 years and lived with moderate arthritis in her knees, which left them stiff and made walking difficult. Stem cells harvested from the bottom of her spine were injected into her shoulder and knees.

She was a bit sore for a week and a half, she says, until she felt as if the procedures “began to work and undo things. The pain went away, and the stiffness went away in the knees, too.”

Knapp paid for the injections out of pocket, since they are not covered by health insurance, but she says it was worth it. The therapy costs approximately $3,750. About three-quarters of recipients report improvements after two months, Goradia says.

He became interested in stem cell therapy about seven years ago after looking into its viability in treating orthopedic conditions. He found it intriguing that stem cells offered a way to “treat and heal naturally.” In 2013, he visited other doctors and watched how the procedure was done.

Goradia says the therapy is a “straightforward” in-office procedure. Stem cells are taken from bone marrow drawn from the back of the pelvis. The cells are separated out in a machine over 30 minutes, then they are returned to the patient in the targeted area under local anesthetic.

The therapy is most beneficial to those seeking help with a condition such as a tendon issue or rotator cuff tear. A large tear may first require surgery, and the injection may speed healing, Goradia says. It may also provide relief — or at least postpone surgery — for those in pain from arthritis in the knees, hips or shoulders.

Goradia says most of the stem cell therapy patients he’s seen are people in their 50s and 60s who have arthritic knees or shoulders. They’re active and don’t want surgery or joint replacements. The injection may cause some bruising or soreness around the injection site, but Goradia says he has seen no complications arise from the treatments.

× Expand Patient Miguel Cordero talks with Dr. Vic Goradia. (Photo by Ash Daniel)

Chesterfield County resident Kate Wiltsie had both knees treated a year ago with injections of a stem cell product at Chronic Care of Richmond and Regenerative Medicine, the practice of chiropractor Bryant Snyder. Wiltsie, a registered nurse, says she was in constant pain and hardly able to climb stairs because of arthritis in her knees. There was no way she could get on the floor to play with her grandchildren.

“It was really reducing the quality of life,” she says.

Stem cells derived from donated placentas that have been frozen and shipped to Snyder’s practice are used for the injections. Wiltsie says she noticed a reduction in her pain in a couple weeks, and it progressively improved. She no longer takes arthritis pain medication and says she is fully mobile and more able to enjoy time with her grandchildren.

Snyder began offering stem cell therapies in April 2018 after seeing what colleagues were doing elsewhere. “I kind of watched to see how it would evolve,” he says. “I was just floored with the results.”

Snyder offers regular seminars in Richmond on how regenerative medicine can be used to deal with chronic pain from conditions including degenerative arthritis, bursitis, tendonitis and degenerative joint disease. He’s done about 720 procedures and says most of his work has been with people ages 60 to 70, but he’s worked with some athletes in their 30s and some who were 90.

Chronic Care offers umbilical cord-derived stem cells from an FDA-approved laboratory in California, Snyder says. The product is shipped frozen to Chronic Care, where it is thawed and injected by a nurse practitioner. The patient is examined by Snyder and the nurse practitioner, and a medical doctor collaborates with the staff on protocols and procedures for patients.

It’s generally a one-time injection, he says, describing the procedure as low risk, using a pediatric-like needle and a freezing spray applied to mitigate discomfort. It takes 30 minutes or less, and is followed with regular evaluations.

Snyder says most people report a positive response to the treatment, generally three to six months afterward, with a decrease in inflammation and pain, better range of motion and a better quality of life — “basically getting their lives back” without relying on surgery or physical treatments or therapies, he says.

He says it’s low-risk because there are no rejections with this type of product, and you don’t need to know the blood type or the DNA of the donor. Injections can cost about $3,000 to $4,000.

× Expand Chiropractor Bryant Snyder and Rene Dreher with a patient (Photo by Ash Daniel)

More Research Needed

Generally, risks are minimal for people who receive stem cell injections for things like rotator cuff surgery recovery or relatively minor ailments such as arthritic knees. And while the treatments hold great potential and promise profound results, how do they measure up?

For now, the research is limited. A Korean assessment of 3,666 studies showed that only 17 met the criteria for a good study, according to Nordt. Also, many results touting stem cell therapies are patient-reported outcomes, not based in science. MRIs or arthroscopic views may show only minor improvements, and the anecdotal evidence needs to be vetted. The science is “still very thin,” he says.

And therein lies the problem. Without good data, there can be no realistic expectations. Nordt says he’s not against people trying it out to see if it helps, but “I find myself 95% of the time talking people out of [stem cell procedures].”

Nordt will give one or two injections to a patient, but only after lengthy conversations, and only to those with conditions that may benefit, such as someone with a degenerative knee, or a partial tear in a rotator cuff.

There also are concerns about inappropriate marketing and unproven claims by some providers, and questions regarding procedures used in some laboratories providing the stem cells.

The federal Food and Drug Administration is calling out a host of businesses that are touting their wares and therapies as cure-alls, sending notification to some laboratories for marketing unapproved products for illnesses ranging from diabetes to Parkinson’s disease.

“We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients and their families with unproven claims about their unapproved stem cell products,” Ned Sharpless, a physician and acting FDA commissioner, wrote in a letter sent to a business in May. The FDA reported that it had contacted 46 companies and providers over stem cell concerns in the past year.

In September, the FDA warned a California-based company about its products taken from umbilical cords and umbilical cord blood for not following accepted procedures involving donor eligibility and environmental monitoring, leading to “potential significant safety concerns that put patients at risk.”

A list of FDA-approved stem cell products is available on the agency’s website, fda.gov. There, an information page on stem cells notes that one patient developed a tumor on the spine after an injection of stem cells, and another lost sight after a stem cell injection in the eye. The FDA also warns that cells that are removed and manipulated could possibly become contaminated. The agency notes that stem cell injections may cause reactions at the site where they are administered; such injections may lead to tumor development; and that the stem cells may not thrive and multiply, or might fail to change into the appropriate cell.

Nordt recommends that as with any surgery, a patient should seek out a second and even a third opinion.

Doctors have to be aware and guard against unintentional consequences. Could the cells escape the immune system and cause a cancer? “Stem cells carry great promise,” VCU’s McCarty says, “but they also carry great issues.”

A CELLULAR MEDICINE PRIMER

Stem Cell: Stem cells renew themselves through cell division. The National Institutes of Health notes that stem cells can be induced to become something else; some can repair and replace worn out, damaged tissue, for instance, in the gut and bone marrow.

“A stem cell can be anything it wants to be when it grows up,” says John McCarty, director of the Cellular Immunotherapies and Transplant Program at VCU Massey Cancer Center.

Types of Stem Cells: Bone marrow is home to 1) hematopoietic stem cells, which can turn into other types of blood cells.

There are also 2) mesenchymal stem cells, which can generate bone, cartilage and fat cells. The mesenchymal stems are found in marrow and in other types of body tissue as well.

There also are 3) epithelial stem cells, found in the digestive tract; neural stem cells in the brain; and skin stem cells at the base of hair follicles and in the basal layer of the epidermis.

Cell-Based Therapies: Treatments in which stem cells are induced to become a specific type of cell and repair damage or destroy certain cells or tissue, also known as regenerative medicine. Cells go to work immediately, but the patient may not notice any improvements for a couple of weeks.

The cells won’t cure arthritis or replace cartilage, but they stimulate and promote healing. The therapy should not be used on people with cancer or those who take blood thinners.

Stem Cell Transplants: In a bone marrow transplant, stem cells are collected from healthy bone marrow and injected. The new stem cells in turn make healthy blood cells.

Stem cells are more often gleaned from blood and blood products instead of from bone marrow. Some companies provide stem cells derived from donated umbilical cords and placentas.

CAR T-cell Therapy: A treatment for some advanced blood cancers T-cells (an immune system cell) are separated from the blood, genetically modified, then infused back into the patient.

VCU Health reports that this type of therapy may be useful in patients who have not responded to chemotherapy. Advantages include less inpatient care vs. chemotherapy, and that “the patient’s own immune system is effectively reprogrammed” to go after cancer cells.

Sources: cancer.net, National Institutes of Health, VCU Health