TRANSPLANTATION PROCEDURES:

1) Embryonic/Fetal Cells: In 1996, the Russian Health Ministry authorized Bryukhovetskiy to carry out limited clinical trials in SCI. In these early trials, stem cells, neurons, and glia obtained from a various tissues, including 12-week-old human fetuses, were transplanted into the spinal cord/fluid of 17 patients with SCI. Their ages ranged from 16-52 (average 30) years, and the time interval between injury and transplantation ranged from 1-20 (average 5) years. Six, ten, and one had Cervical, Thoracic, and Lumbar injuries respectively. In addition to cell transplantation, all had a variety of other procedures performed depending upon their unique injuries.

Before treatment, 14 subjects were ASIA grade A and three were grade B. After transplantation (0.5 - 3-year follow-up period), four were grade A, five grade B, and seven grade C.  Fifteen had some sensory improvement, seven had Motor improvement, and 12 had improved bladder function.

2) SpheroGel & Autologous Cells: Bryukhovetskiy’s team has implanted SpheroGel (a biodegradable polymer matrix) with embedded cells in six patients who required reconstructive surgeries. In three, hematopoietic stem cells were embedded, and, in the three others, olfactory cells. At follow-up (3-8 months), two grade-A patients had improved to grade C, and one had advanced to grade B. In one patient (grade B initially), there was no improvement.

3) Intrathecal Stem-Cell Transfusion: The intrathecal transfusion of autologous hematopoietic stem cells is the procedure most currently used. In this relatively straight-forward procedure involving no surgery, the patient’s stem cells are collected without anesthesia and stored with viability until they are transfused back into the patient.

To stimulate hematopoietic stem-cell production and, in turn, cell accumulation in the blood, patients typically received eight subcutaneous injections over four days of granulocytic colony-stimulating factor, a drug also called Neupogen® or Filgrastim. On day five, the patient is hooked up to a blood separator. Over 3-4 hours, blood is drawn from a vein; processed by the separator, which isolates the stems cells; and returned through another vein.

The collected stem cells are concentrated by centrifugation and slowly frozen in liquid nitrogen (-170o centigrade) in the presence of dimethyl sulfoxide (DMSO), a cryopreservative that allows cells to be frozen with minimal damage. Care is taken to check for infections so that they will not be later introduced behind the protective blood-brain barrier during transfusion.

At the time of transfusion, the stem-cell suspension is thawed and about 5.3-million cells injected intrathecally into the subarachnoid space (i.e., into the spinal fluid) through a L3-L4 lumbar puncture using a local anesthetic. The procedure, which I observed, is quick and straightforward. The patient can repeat the transfusion in two months. Bryukhovetskiy believes multiple transfusions enhance Functional recovery.

In contrast to hematopoietic stem cells, positive results have been limited with the intrathecal transfusion of olfactory cells, previously isolated and cultured from the patient’s nasal tissue.

Although Bryukhovetskiy’s team has collected stem cells from about 120 patients, for a variety of reasons, including the presence of latent infections, only about 60 have had cells reintroduced. Of these 60, 18 have had the recommended multiple transfusions. In turn, 61% of the 18 showed some functional recovery, in some cases dramatic.

Because most patients’ transfusions were relatively recent, it is too early to assess long-term benefit.  Early improvements are unlikely caused by comparatively slow neuronal Regeneration processes and are probably triggered by altering the injury site’s Environment through the secretion of growth factors and other molecules.

For more scientifically inclined readers, Bryukhovetskiy hypothesizes that the stem-cells’ regenerative effects are mediated through an important growth factor called ciliary neurotrophic factor (CNTF) and its interaction with a key transmembrane receptor called gp130. This interaction, in turn, influences cell differentiation.

PHYSICAL Rehabilitation:
Like others who are developing function-restoring therapies, Bryukhovetskiy strongly believes that improvement after treatment depends upon the patient’s commitment to aggressive physical rehabilitation designed to maximize restored function. Basically, if muscles have been disconnected from brain control for many years, it’s going to take some real work to build up nascent connections. As such, his clinic emphasizes diverse rehabilitation modalities, ranging from aggressive exercises to passive massage and acupuncture therapy.

PATIENTS:
I had the opportunity to interact with a number of NeuroVita patients. Because their treatments have been relatively recent, accrued improvements have been generally modest.

Vladimir, a 40-year old Russian living in Spain, sustained a thoracic T6 complete injury from a 2001 car accident, and started a series of stem-cell transfusions late last year. He believes that these recent transfusions, combined with extensive Physical Therapy, has resulted in additional leg movement, including the ability to walk in a swimming pool.

An articulate 19-year-old Russian living in Bulgaria, Dmitri sustained a cervical C5-6 injury in a 2000 skiing accident. He has had three transfusions since the beginning of 2005 and has noted new sensation and sweating. He had some slight headaches soon after the transfusions.

>From Dagestan, Baziat, 21, sustained a T9-11 injury when she was 19. After four transfusions, she has regained additional leg and hip function.

Alexey, 32, traveled in from the distant Kamchatka Peninsula on Russia’s far eastern Pacific side, much closer to Alaska than Moscow. He shared with me the challenges of living with a severe physical Disability in a remote, almost frontier-like area of Russia. Sustaining a T-8 gunshot injury 11 years ago, he received his first transfusion last year and was scheduled to receive his third during my visit. He has acquired more bladder and bowel function and has increased leg strength and tension.  

Olga, 17, sustained a T8-9 injury seven years ago from an accident. Last year, cell-containing SpheroGel was implanted in the 4-cm gap in her spinal cord. Since then, she also has had six intrathecal transfusions. Olga indicated some increased lower-back strength and improved “inner sensation.”

A year after injury, another Olga had the 5-cm gap at her T12-injury site filled with SpheroGel embedded with regenerative cells. About a year after surgery, she suddenly started gaining some dramatic improvement, which she demonstrated to me in NeuroVita’s rehabilitation facility.

These are just the patients that I met. For those interested in further patient feedback, the clinic has developed a DVD with English subtitles that includes interviews with other NeuroVita patients.

CONCLUSION:
Although by itself probably not an end-all SCI panacea, this Russian stem-cell therapy is an exceedingly important piece of the puzzle that brings us ever closer to our overall goal of restored function after injury. Hopefully, American scientists can open-mindedly establish collaborations with Bryukhovetskiy so that Americans with SCI can more readily benefit.

Although Bryukhovetskiy’s work is of paramount importance, when discussing hot scientific topics like stem-cell therapy, it is easy to lose track of the fact that it is the patient who ultimately counts, not the science. In science’s cold objective eye, the patient becomes a research subject characterized by an Impairment-scale, etc, and whose subjective opinions are often left in the dust of our quest for scientific purity. 

I was grateful for the opportunity to interact with NeuroVita’s patients, appreciating their willingness to share with me not only their pain and frustration, but their hope, optimism, and belief in the future. As a somewhat jaded disability-research veteran, their spirit fueled mine.

In this clinic and others throughout the world I have visited, the face of SCI seems so similar. Often with the support of devoted parents, youthful patients with great resolve, motivation, and old-soul wisdom that belies their youth pursue their dreams of recovery unencumbered with the limited expectations of the past.

In spite of unique injuries, there seems to be a collective “soul of SCI” in these patients that transcends culture and country. Although the efforts of innovative scientists, such as Bryukhovetskiy, are invaluable, the patients are the true pioneers. They each send forth a ripple of hope that is converging into a powerful current which will inevitably wash away SCI’s imprisoning walls.

Contact Information: NeuroVita Clinic, Kashirskoye Avenue 23A, Moscow, Russia; info@neurovita.ru or www.NeuroVita.ru.

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