Stem cell treatments—YEA OR NAY?
Around the beginning of June 2014, I discovered a discussion regarding stem cell treatment on The Myositis Association website.
John Schell posted the following on April 28, 2013: “At our KIT meeting last Sat. one of our regular attendees just came back from being treated with belly fat stem cells. He has been able to regain some of the functions he had lost and is now able to do most of his own personal care again. He can now lift his arms up over his head and move his legs off of his wheelchair footrest. His hair is growing and filling in his bald spots. The best news though is that for the first time in the three years I have known him he is gaining a little hope. I am doing my own research on this treatment and trying to sort fact from false hope. I am wondering if anyone else has any experiences in this area?
“I have always been optimistic and believed that medical science is going to turn up a treatment that would change our status quickly. Even if one of the treatments being tested at this time were successful in their trials today, the general population with IBM would still be several years away from receiving any treatment. That is because the approval process would still take a couple of years for approval of the drug.
“Stem cell treatment would be available immediately as they are not regulated by the FDA as they are using your own stem cells and putting them into your own body. Unfortunately this can also lead to unqualified persons taking advantage of our plight. (ie the report on 60 minutes this year about the promises that were made to sufferers of ALS)
“In any case I thought this discussion might lead to a discussion we haven’t talked about a lot in the past.” John Schell, in TMA Community Forum
John’s anecdote and decision helped us to reach a decision to go ahead with the treatment. While not wanting to be taken in by a scam of any sort, I believe that this treatment offers a lifeline of hope. The cost for the treatment is not covered by insurance or Medicare. It is not FDA approved, but the particular site I researched states that same-day delivery of my own cells falls within the guidelines set by the FDA.
Initially, I heard of two sites that offered this treatment—Phoenix, Arizona, and Boca Raton, Florida, —somewhere near Miami. Charles and I decided to consider the one in Phoenix as we made our way westward to the myositis conference. We talked with a plastic surgeon, Dr. Paul Holden, who is one of several physicians who do the procedure there in Phoenix.
Said procedure is complete in one day with an examination of the donor site the following day. Then we could be on our way home. The facility would continue to monitor my response for a period of three years as part of an investigational study to secure approval of the procedure. Monitoring would be completed by telephone calls or Skyping. This procedure involves usage of stem cells from my adipose tissue, which is removed by liposuction, and then cleaned up. The course he recommended was to use approximately 60% of the stems in direct injections into affected muscles: quads, hamstrings, left shoulder, and hands. The other 40% would be infused into my blood stream. The cost in Phoenix was $11,000.
As I continued to research stem cells and differences among them, I noted that bone marrow taken from my own body was both a lengthy and painful process. Using any stem cells from another adult runs the risk of donor rejection and other possible consequences. There are more stem cells immediately available by using my own adipose tissue cells. I am sure that I have over-simplified this information, but it is my take-away of complicated research. Actually in doing further research, I feel more positivity regarding the treatment.
Further research into stem cell treatment centers led me to the discovery that there is a Mississippi Stem Cell Treatment Center in Ocean Springs, Mississippi. We made an appointment with Dr. Hazem Barmada for a telephone consultation about the process there. Because I have so many muscles affected by this disease, he plans at this point to do 100% infusion of the adipose stem cells. If there is a need for follow-up treatment, the price is basically at his cost, or one-half of the $7,200 cost charged for the treatment. He has not done any other infusions of myositis patients but two weeks previous he had treated someone with muscular dystrophy. He did inject into this patient’smuscles. His plan is that he will meet with me the day prior to the treatment, look over my records, and, together, we will make the decision about the best course for me. He took approximately 40 minutes answering Charles’s and my questions.
Dr. Barmada is a former cardiovascular surgeon, who was trained at the University of Manchester in England. He acknowledges that this treatment is still in its infancy but stated his fascination with the possibilities of stem cells. This fascination led them into this new area of treatment after he retired.
So my decision wryly stated is the following: Do I get stem cell treatment from the snake oil salesmen in the desert or from the voodoo magician in the marsh? Actually, I feel very comfortable in choosing the doctor and facility that are more local. This is an earlier probability than waiting until after the conference, and I like the possibility of subsequent treatments being only three hours away, if needed.
Dr. Barmada’s wife who has a doctorate in biochemistry will perform the magic with the cells. My friend, who is a noted biology-chemistry-physics teacher, was very encouraging and reminded me of many firsts in Mississippi medical news. I love Mississippi, but the only area of pride concerning top 10 and bottom 10 lists is our placement on lists of states that are altruistic/generous. I am well aware in that as in all things, caveat
and carpe diem!
Dr. Barmada sounds as if he is someone who is interested in seeing good results. At this point, he will do the infusion on July 16 and will possibly use a drug called mannitol, which supposedly passes the blood/brain barrier. All in all, I am very eager. I had the physical therapy evaluation today, July 2, 2014, to document her findings. I will continue working with the physical therapist and get another evaluation on record in approximately two months. As to the financial considerations, subsequent treatments, if needed, will be made available at his cost, somewhat less than half-price. I hope that includes my osteoarthritic areas!
Another factor influencing my decision is my mother’s participation in a clinical study in usage of gold salts in the treatment of rheumatoid arthritis. She benefitted from this test and continued to go regularly for her “gold shots” throughout the remaining years of her life. When she agreed to participate, outcome was very uncertain.
To begin with a self-assessment of my abilities, I will use the functional rating scale for inclusion body myositis with my own subjective opinion.
Inclusion Body Myositis-Functional Rating Scale (IBM-FRS)
– 4 Normal
– 3 Early eating problems-occasional choking
– 2 Dietary consistency changes
– 1 Frequent choking
– 0 Needs tube feeding
At this point, I have no swallowing difficulties. I rate 4
B. Handwriting (with dominant hand prior to IBM onset)
– 4 Normal
– 3 Slow or sloppy; all words are legible
– 2 Not all words are legible
– 1 Able to grip pen but unable to write
– 0 unable to grip pen
At this point, my handwriting has undergone no changes, though my left-handedness with the keyboard seems to require more concentration to have the strength to form the letters, particularly with the pinky. I rate 4
C. Cutting food and handling utensils
– 4 Normal
– 3 Somewhat slow and clumsy, but no help needed
– 2 Can cut most foods, although clumsy and slow; some help needed
– 1 Food must be cut by someone, but can still feed slowly
– 0 Needs to be fed
At this point, I rate a 3+.
D. Fine motor tasks (opening doors, using keys, picking up small objects)
– 4 Independent
– 3 Slow or clumsy in completing task
– 2 Independent but requires modified techniques or assistive devices
– 1 Frequently requires assistance from caregiver
– 0 Unable
This area is somewhat difficult to rate. If I were trying to use my left hand, the rating would be 0+. The ability to grasp or grip with any strength is not present. I can still use my right hand for most fine motor tasks. Other physical limitations make for difficulty: getting in position to pick something from the floor, for example. Fatigue plays a strong role in doing any of these tasks. I have a reacher, but maintaining it in a locked-down position by squeezing the levers and keeping it in the desired area sometimes is insurmountable. Frequent drops are normal.
I rate this area as two for the right hand, zero plus for the left. Overall a 1.
– 4 Normal
– 3 Independent but with increased effort or decreased efficiency
– 2 Independent but requires assistive devices or modified techniques (Velcro snaps, shirts without snaps)
– 1 Requires assistance from caregiver for some clothing items
– 0 total dependence
I rate this area as a two for most items but will ask for my husband’s help if he is nearby. 2
F. Hygiene (bathing and toileting)
– 4 Normal
– 3 Independent but with increased effort or decreased activity
– 2 Independent but requires use of assistive devices (shower chair, raised toilet seat, etc.)
– 1 Requires occasional assistance from caregiver
– 0 Completely dependent
I bathe myself in a modified- for- dependency shower. The shower has no edge to step over, slopes to a central drain, and has a shower bench installed. Shampooing has become more difficult as I use only the right hand, unless I lower my head to almost waist level. Because of safety concerns, Charles assists me in getting out of the shower. The shower seat is no longer high enough for me to arise without help. I have difficulty in turning/pivoting to my seat because my right knee frequently buckles. I rate this area 1.
G. Turning in bed and adjusting covers
– 4 Normal
– 3 Somewhat slow and clumsy but no help needed
– 2 Can turn alone or adjust sheets, but with great difficulty
– 1 Can initiate, but not turn or adjust sheets alone – 0 Unable or requires total assistance
I lie on my back as this is the best position when I consider degenerative discs. Charles places pillows under my knees and a pillow at the end of the bed to keep the covers from my toes. I only turn to my side by use of a foot-high rail; that is only used when I get up from bed. If my covers are more than sheet and a light spread, Charles assists me. I rate a 2
H. Sit to stand
– 4 Independent (without use of arms)
– 3 Performs with substitute motions (leaning forward, rocking) but without use of arms<br / – 2 Requires use of arms
– 1 requires assistance from a device or person
– 0 Unable to stand
I use a Lift-Seat toilet attachment, an elevating chair, and a recliner that is powered to help me stand. I have been unable to rise from a seated position for several years. I rate 1
– 4 Normal
– 3 Slow or mild unsteadiness
– 2 Intermittent use of an assistive device (ankle-foot orthosis, cane, walker)
– 1 Dependent on assistive device
– 0 Wheelchair dependent
I am unable to walk. 0
J. Climbing stairs
– 4 Normal
– 3 Slow with hesitation or increased effort; uses hand rail intermittently
– 2 Dependent on hand rail
– 1 Dependent on hand rail and additional support (cane or person)
– 0 Cannot climb stairs
I rate climbing stairs 0
Total score is 18 out of a possible 40.
The IBM-FRS addresses swallowing, handwriting, cutting food, handling utensils, dressing, hygiene, turning, isometric strength and manual muscle testing.
Source; Inclusion body myositis: old and new concepts
J. Neurol. Neurosurg. Psychiatry 2009;80;1186-1193
A A Amato and R J Barvv
Friday, July 18, 2014
Yeah-we did it! We went to MS Stem Cell Treatment Center in Ocean Springs. Dr. Hazem Barmada incised my love handles in the back area; his wife, a Ph.D. in biochemistry, did the separation of the stem cells from the fat; then he infused 4.5 ml back into my body via a port on my arm. I chose not to have the blood/brain barrier medication, mannitol, added as i wanted God to get all credit due him for any miracle, not a medication.
We finished around one; it is now 4:20, and I can both feel and see a difference in improved hand strength. One of the standard tests performed by a neurologist requires the patient to make a circle with thumb and forefinger to test resistance when he pulls against the circle with his finger. I have performed this test as a regular practice and had noted very little resistance. On the way home from Ocean Springs, I formed these telling o’s with resistance enough that it was difficult for me to break. In addition, as we were traveling home, Charles received a phone call. His phone was in his right pocket on his hip, and he had to undo his seatbelt to get to the phone. That action was not difficult for him to perform, but to repeat that action after getting the phone proved to be more difficult. Unsure of what actions my left hand would be able to do, I reached over to hold the receptacle steady. I was successful. I was euphoric!
At this point no one knows if the benefits will last. The first inclusion body myositis drug will not be available until five or more years have passed. The test site for this drug nearest to me was unable to get up and running in time to be part of the trial. We had already pretty much ruled it out anyway as it would require a 3 to 4 hour drive to Dallas. Even if I had been chosen as a test subject, there was no guarantee that I would be one of the ones chosen to receive an actual dosage of the Novartis medication. I do not want to get my hopes and expectations up too much, but I am encouraged. It is my prayer that this will be an on this effective treatment for me and for others.
Let’s see if I can throw a softball farther!
Just before the procedure, the distance was a little over a yard.
Monday, July 21, 2014
My left hand continues to grow in strength and ability to grasp.
My regular medication for pain spread over a day’s time was two hydrocodone, two tramadol, and four 300mg tablets of gabapentin/Neurontin. Since the treatment, I have taken two tramadol tablets because I didn’t put shoes on in time to keep irritation/inflammation away from my ankle. I have also been using light weights to strengthen my muscles! But, for me the biggest news is that I stood up straight four times today. Keep in mind this was by way of lift chair, but I held onto a chair in front of me and held the position several seconds, (previous standing attempts are with my being bent over with back almost parallel to floor–definitely not pretty!)I don’t yet attempt to make a step. It takes many muscles to stand and to step. Isn’t it amazing the blessings God gives us that we take for granted? When was the last time I said, “Thank you for the gift of sight”? I also shampooed my left side of my head with my left hand—could not reach over to the right side yet as my right has had to reach over to the left. Plus, I got myself into and out of the shower with Charles nearby. He did not have help lift me up although he did but his hands on the hip to steady me. Baby steps mean much!
Friday, July 25, 2014
Almost daily I can feel an increase in strength; this may not be measurable by someone outside my body to the degree that I feel the change. Charles is able to see many of these tasks that I do made easier. This morning as I got out of bed, I used my right hand to throw back the sheet and the spread with minimal effort. I easily brought my knees up. I held on to my rail with my left hand and sat up in one motion, swung my legs over to the left side, and I was on the floor. Yesterday I got my shower with no help in and out. It will probably be sometime before I trust myself not to fall; I still want Charles to be with me in the house, but he does not have to be in the bathroom with me. My keyboarding skills have improved with my being able to use my left hand.
Two days earlier I loaded the dishwasher. My dishwasher is located to my left side, so for a couple of years Charles has taken on that duty. I have not yet attempted to unload it; this action requires more strength because there’s no momentum downward. I think I’ll try that today. I can reach into the refrigerator with the left hand and grasp a jar or bottle and bring it out.
I’m pretty sure that Charles is anticipating more home-cooked meals. Our diets have not suffered thanks to frozen meals. Together we probably cooked two full meals a week; we frequently ate homemade fast foods and leftovers from the large meals. Breakfast for me is typically a small container of yogurt; although I might have preferred something different, I was still in the process of losing prednisone pounds and found the yogurt with a midmorning fruit snack was enough. We ate our large meal in the middle of the day; however, this large meal might consist of soup and a sandwich or salad. Frequently the choice for supper was fruit. Over the past three or four years with effort only through dieting, (Without access to a swimming pool, I had given up on any exercise though I still attempted to be active with hobbies.) I have lost 44 pounds; I am still mildly obese but close to being merely overweight-another 12 to 14 pounds to be back at the beginning point of this disease and the subsequent use of prednisone and methotrexate.
Another improvement is seen in the area of medication: I continue not to need the Neurontin or gabapentin for the referred nerve pain from my degenerative discs and facet joint in my hip. I do take the pain medication particularly for the hip as I’m still sitting in an easy chair most of the day. I have noticed that the exercise diminishes the pain as my posture is better, endorphins released, and serotonin is increased.
Over the past week, my exercise has increased from none to almost 45 minutes with a time separation between the upper body and lower body strengthening and stretching. When I know I can assist myself in getting up from the floor, I know I will be able to return to better stretching.
I don’t want to give Charles more to do or to make things harder for him. He wants me to get better for my sake not his, but I do know this illness has taken a toll on him as I still outweigh him by about 20 pounds. Of course, over the past few years, he has lost about 20 pounds as well. He has been blessed with a runner’s body: long, lean, and strong. I’m already 65 and he is almost 65 years old.
Only this week he used his chainsaw to cut into four sections of trunk a large tree that had 32 rings. He wrapped chains around each section and dragged them to the burn pile with the tractor. With the tractor engine turned off, he heard my yells for help. With my newfound strength, I had taken kitchen waste down to the composter. I found I needed to rinse my container and put some water in the compost bin. Not paying quite enough attention, I had neither lowered my elevation from getting water inside, nor had I decreased my speed from being outside. Coming down the ramp, these factors caused me to be thrown from my seat. I landed on my right side on the concrete floor of the garage. I was aware that I could have gotten myself into a seated position but I did not know how long it would have to be maintained before he arrived to get me back in my chair. I was not hurt, but I was quite conscious of the further effort he would have to expend on my behalf. We have an instinctive fear of falling, and I think this is more pronounced in those of us who have IBM because we are at the mercy of others in getting up. From the garage surface I had nothing to hold onto as he stood me up; giving up the control of my hand or hands on a steady surface is so difficult! I cried a quick prayer,” Help me, Jesus!” He returned me safely into the chair. Charles gave me a lecture on how not to repeat these transgressions. Duly noted!
I also am able to reach with my left hand over to the right side of my hair for shampooing, if it were needed.
Last week one or two days prior to the procedure, TMA had issued a warning of scam artists/ doctors who might be promising benefits for IBM patients. Although this warning gave me pause, I had already committed to the process. So far for me this does not appear to have been a mistake. I don’t know if improvements will continue to come or if the present improvements will last, but I do recognize there have been improvements that cannot be explained away by placebo effect.