Experimental Therapies

[Wise Young]

In the past several years, a number of clinical centers are offering a variety of experimental therapies. Since these are not truly "clinical trials" in the sense that they are looking to gather evidence for safety and efficacy for FDA approval, I hesitated to create individual topics for each. However, if there is interest and demand, I will establish individual topics for each.

[dprast]

Wise,
I think there is certainly interest in the therapies or "interventions" being conducted around the world in SCI repair. I'd be interested to see more about the trials in Eastern Europe and Taiwan and elsewhere . It is the World wide web after all !
A listing for each of these "therapies" would help to build a database of attempts and successes and might encourage feedback from the participants.
Thanks for your amazing energy Wise
David

[Carl R]

I believe the experimental therapies should be included under a separate topic for each. I would think it is just as important to build a database of therapies which have not shown success. One of the problems I have found so far in looking for more information on spinal cord is that there are lots of treatments available and not a lot of data behind a lot of the treatments. It seems most medical professionals like to publish results on their successes, yet failed to publish the failures. (especially outside the U.S.)

[Wise Young]

I am convinced. I will start new topics on the places that are including experimental therapies even when there are no formal trials. Just a quick question, however. For example, should I include some controversial therapies such as Neuralyn, Shark Embryo Transplants, etc.? Wise.

[Carl R]

on the controversial stuff. There needs to be a line drawn somewhere, otherwise we would have to list " Miss Cleo ".

Rule of thumb might be to list only the treatments that someone in the community here has first hand knowledge of.

[Sue Pendleton]

I think the only trials or novel therapies that should be left out or at least are further identified so people do not waste a lot of time on them are--those that are currently under investigation for fraud by a state's attorney general or the equivalent in another country. So I'd leave Neuralyn out or better yet--identify it as fraudulant so no one else wastes money on it. As for shark cartlidge.....it does appear that at a certain time after injury some kind of irritant might actually help further recovery. Not that I'm letting anyone stick shark cartlidge in me, mind you. http://sci.rutgers.edu/forum/images/smilies/smile.gif

[giambjj]

How about the Spinal Regeneration Center in Tijuana, Mexico. The are doing reconstructive surgery on the spinal column, skark stem cell transplantation, laser puncture, and 4-AP injections.

[Wise Young]

I am trying to gather together all the material relating to the Tijuana Center that is doing the shark embryo transplants and will post soon.

[Birde]

Dr. Hernando Rafael's (Mexico, City) email is yasherma@lycos.com. Although
he understands English, he prefers to correspond by email, which he can
understand better. http://www.electriciti.com/~spinal/ 416 W San Ysidro Blvd L-264, San Ysidro, CA 92173
Phone: 0115266 or Email: spinal@electriciti.com
Research Center that supports work of Dr. Fernando Ramirez del Rio, who has been using embryonic cell transplant therapy in Tijuana, Mexico. Provide information on the treatment and cost of this program.

[Wise Young]

In the coming few days, as soon as I get a little breathing room, I will try to get a few other therapies up on this board... this includes the Tijuana shark embryo transplants, Khouri's mixture to regenerate the spinal cord, etc. People should post any information or their opinions of the trials under each of the topics. I find it very interesting that some of the trials have received almost no page views by the community.

Wise.

[Birde]

Help Me Walk
Masha Malikina surrvived the Chernobyl nuclear disaster. But can she recover from a car crash that has left her paralyzed?

Virginia Parker
Special to the Jewish Time


--------------------------------------------------------------------------------

ALONE

I have a wall around my heart of stone
I can't help but feel so utterly alone
I wish I could escape this dark, cold place
But when I look in the mirror, I see pain written on my face
It's scary to be left alone with your own mind
The peace within which used to be so easy, is now hard to find
How can I battle these monsters from deep inside
There is no place that I can run and hide
How do you overcome yourself and win
When you don't even know where to begin
Everyone around me thinks that I am strong
I'm so scared of the fact that they might be wrong
As I see it two choices stare me in the eye
To fight and win or crumble up and die
- Masha Malikina

The car bolted out of control. With five teens trapped inside, the red Acura Integra skidded 30 feet, plunged down a Lawrenceville Highway embankment in Lilburn and ricocheted off three trees. It landed upright with the hatch door gone and the engine still running. Masha Malikina, 15, closed her eyes during impact, but didn't pass out. Her face ached. Blood seeped from her body. Muffled cries echoed from the other injured freshman and sophomores - Armando Chavez, 14, Sabina Medzhidova, 15 and Nadia Marinia, 14. The driver, Arsen Vartanyan, 16, slumped over the wheel, unconscious.
Masha tried to lift herself by grabbing the torn metal of the roof. She couldn't. Masha wiped her mouth, touched her jeans and saw blood all over her pants. She tried to crawl out and get help. But her body wouldn't respond.
"At first I thought I was okay," Masha says during an interview in her sparsely decorated Lilburn home. "But I couldn't move my legs and my back hurt so bad. I knew it was broken."
Masha, a beautiful, exuberant young woman with blonde hair and a sunshine smile, sits in her wheelchair. What was supposed to be a 10-minute ride home from Berkmar High School on the afternoon of Oct. 29 appears to have changed the course of life for this Russian Jewish emigre and former athletic honor student. Now, her only concern is walking or finding a way to recover some - any - movement in her legs.
Flanked by her loving mother, Nina, Masha talks about her legs. She says they hurt. Bad. Real bad. They are uncontrollable.
"They jump and jerk, they throw me," says Masha. "They tighten up my stomach and I can't breathe. This goes on all night."

Last chance?
After two operations and months of rehabilitation, Dr. David Miller, Masha's neurosurgeon, and other Atlanta specialists have told the teen that her chances of walking again are as grim as 2 percent. They suggest she concentrate on learning how to live an active life, albeit one confined to a wheelchair.
It's a fate Masha has refused to accept.
So later this month, Masha and Nina will be in Mexico to undergo an alternative surgical procedure not yet approved in the United States. It is, perhaps, her last chance to recapture the life any teen expects to live.
The Malikinas learned of the procedure in an e-mail from another Russian emigre family, whose son had damaged his spine in a motorcycle accident, but recovered some function after an operation in Mexico. "He is now walking with braces," Masha says.
On May 27, Masha flew to San Diego to consult with Dr. Fernando Ramirez Del Rio of the International Spinal Cord Regeneration Center and was told she is a good candidate for the alternative surgery. While Del Rio's procedure has critics, Masha says it is the only logical step for her to take.
"If every doctor is telling you that you will never walk and one doctor is saying he can help you, you listen to the one who will help," explains Masha, who is paralyzed from the chest down. "I have seen many neurosurgeons in the U.S., but only one specialist says he can perform a surgery which has a very good chance of repairing the damage to my spine and will allow me to walk again."
Atlanta doctors say Masha's window of opportunity for maximum improvement from her spinal injury is 12 to 18 months, so she needs to act now. The cost of the operation is $57,000, but it is not covered by insurance. Masha's initial medical costs have exceeded $300,000. So far, most of this has been covered by Nina's employer's insurance.
Last month, Masha and Nina appealed to the Jewish community for help to raise the necessary funds. Not active at all in Jewish life, they had been disconnected from the Jewish community and hadn't made serious efforts to make it aware of Masha's plight. But when Ralph Parker, a Jewish activist who aids various refugee communities, heard about Masha, he swung into action.
Parker says he faxed a letter of appeal from Masha to every synagogue in Atlanta the week of July 3. He followed up with a few phone calls on July 7, asking them to please pass out the flier and make an announcement. Earlier, he faxed a similar letter to a few Jewish community agencies.
"The only one to call me back was The Temple," Parker says. And the Jewish Times. "I hope the Malikinas get some angels who will step forward and say, 'yes, let's do something,' " says Parker. "Someone reading this article may be proficient in this area and get involved."
One of those angels is Elena Corbet, another Russian Jewish emigre and family friend of the Malikinas. Elena, who became a Baptist after remarrying in the United States, brought Masha's story to the Willeo Baptist Church in Roswell, which created a Web site for Masha and posted it on its homepage. Elena was also the one who recruited Ralph Parker to the cause.
Through their combined efforts and via a worldwide network of Russian nationals, the $25,000 down payment for Masha's surgery was raised.

Journey from Chernobyl
Born in 1984 in Minsk, Belarus, abandoned by the father she never knew, Masha Malikina's first challenge was to survive the Chernobyl nuclear power disaster that occurred in April 1986. A chain reaction created explosions that blew off the reactor's steel and concrete lid and released radioactive substances estimated at 16 million times that of the Three Mile Island accident in Pennsylvania.
"All the smoke and radiation went up in the air and the first rain fell on us," Masha says. "I remember when it started raining, everybody would put on their hoods and run inside, afraid our hair would fall out. Everybody got sick."
Masha's grandfather and grandmother were diagnosed with cancer. The little girl developed an open wound in her intestine, eight centimeters in diameter, and suffered internal bleeding. Doctors told the family to leave the country for better medical care or Masha would die. The Malikinas applied for Jewish refugee status in 1989 and emigrated to Chicago in 1991.
"She had to have many tests and shots," Nina recalls in her broken English. "But after couple of months Masha was completely changed - she grows 15 centimeters [approximately 6 inches]."
Initially, Nina was forced to accept Medicaid and welfare. She had to care for a sick child, couldn't speak English and couldn't find a job. But as Masha's health improved, Nina was able to learn marketable skills, while Masha attended a transition school funded by the Jewish community. The school, says Masha, was filled with Russian children and Jewish and American teachers. "We met a whole lot of Russian people who came over like us and were struggling to make it," she recalls.
In 1993, her grandparents joined them. Nina was offered a contract job for a computer firm in Norcross, and the family moved to Atlanta.
Masha adapted quickly to her new environment and made many friends at Simpson Elementary School. Her most difficult time was during fifth grade, when her grandfather died from leukemia. "That was a big deal for me. I loved him more than anything," Masha says. "When he would have fever I put cold cloths on his head for him. And I would rub his feet to help make the blood clots disperse a little bit."
By the time she entered Sweetwater Middle School, Masha began to excel academically and was transferred into the gifted classes. She also worked after school at East West Karate.
The Friday afternoon of the accident, Masha was filled with anticipation. The weekend was going to include a Halloween party, and Masha had her costume ready. She was going to be a gypsy. But instead of a carefree holiday, Masha found herself in the hospital emergency room.

The hurt
The ambulance arrived within four minutes of the crash. Medical helicopters airlifted Masha from the scene to North Fulton Regional Medical Center. "I remember, in the helicopter, the sun was in my eyes all the time," Masha recalls. "I was hurry up, hurry up and get there. It all seemed to be going in slow motion."
In addition to her injured back, Masha was suffering from a fractured cheek, a puncture wound in her left arm and a ruptured spleen. Masha's best friend, Deena Bakir, rushed to the hospital.
"I have this scorpion pendant necklace I've had it all my life; my mom got it before I was born," says Masha. "I gave it to Deena and said something stupid, like, 'I want you to have this if I die.' " Deena put on the bloody jewelry, fighting back her own tears to help her friend stay strong.
Nina arrived hours later, delayed by the Friday afternoon traffic. She still was dressed in the gypsy Halloween costume she had worn to work. The Bakir family was waiting with comfort and support. "The family looked after us both," Nina remembers.
That night Masha underwent surgery to remove her ruptured spleen, during which her right lung collapsed. Her spinal cord was twisted and crushed, not severed. The doctors were puzzled by the twist until Masha explained that she had leaned over to cover the girl next to her in the car, so she would not fly out the window. Masha believes this good deed is what ultimately will permit her spine to be repaired. Were it severed, her paraplegia, by all accounts, would be final.
Friends and students gathered at the hospital for an impromptu vigil. In the weeks to come, schoolmates brought banners, balloons, cards and stuffed animals. "There were people there who you never imaged would come. You see who really
is your friend in a situation
like this," Deena recalls.
Masha underwent back surgery the following Monday, Nov 4. It only helped stabilize her already injured back. She then began the ordeal of recovery in a rotor bed. "It was terrible," says Masha. "I was on so many drugs that first week that I had bad hallucinations and horrible nightmares. It was so scary. You don't know where you are, but you have this pain."
Meanwhile, her mother slept on the floor of the hospital waiting room in a sleeping bag.
After three weeks, Masha was transferred to Shepherd Center, where she would stay for months to learn skills to cope with paralysis. Her friends threw her a surprise 16th birthday party at the facility.

Emotional and social support
The family had to sell its two-story house with a steep driveway and move to a one-story home on a level lot that could be modified for Masha's needs. Carpet went out, wood floors went in. The family car was traded for a van that could accommodate Masha's wheelchair. Other changes are more subtle.
There was a boy, who Masha says she dated before the accident. He visited her once at the hospital, but never came to Shepherd. "He was like, 'hi buddy,' in the hall at school [after Masha returned] and I quit talking to him."
Her best friend, Deena, hangs out a lot more at Masha's house, because her own house is two-story and carpeted.
"This has opened my eyes to life," Deena says. "Like how people judge you. You shouldn't care if someone is handicapped. People make little smart jokes and I see it differently now. And I have to have my seat belt on. My brother always made me before; now it's because I want to." Masha and the two other teens in the back seat were not wearing seat belts at the time of the crash.
Nina says she tried to get help from the Jewish community, but couldn't make calls from her workplace. "Some people call the Jewish community service who help people like us and said they will get in touch with you, the secretary will call you after work. But nobody called us," she said.
Ironically, although no one returned Nina's calls or contacted her with assistance, she says she has since been called repeatedly by the same agency asked to donate money.
The Jewish Times contacted Lee Anne Rubenstein, with Jewish Family and Career Services (JF&CS), who oversees Refugee and Emigrant Retraining and Employment.
"Ralph called and told me about the situation on June 26," says Rubenstein. "I didn't hear about it earlier. When I mentioned this to my resettlement program director [Irina Nikishin], she said hadn't heard about it."
Rubenstein says she disseminated information to a few people she knew on "a professional level," who may be able to help. She also mentioned a few transportation programs and other services that JF&CS could provide to Masha, and said that, "the family needs to call and say, this is what I need."
A few days later, Gary Miller, executive director of JF&CS, called Nina Malikina at work and said his agency would do all it could to help. Miller told the Jewish Times that he assured Nina that, "we'd get in contact with her when she and Masha return from Mexico on Aug. 6." Miller also gave her his direct line. "She was really nice, and we look forward to being involved," he said.
For Masha, it is now or never. Awaiting surgery in Mexico, she soon will know whether she ever will walk again. Knowing people are there to support her helps.
"If I could tell other kids anything it would be, 'You think it can't happen to you, but it can. Look at me.' "

[Birde]

Spinal treatment could give Jason back his independence




A PARALYSED Guildford man hopes a new life is on the horizon after treatment he is soon to undergo.
Jason Alner, of Park Barn, is scheduled to fly to Tijuana, Mexico, in June to begin a spinal regeneration treatment program that claims it will give him back some muscular control, and the possibility of independence.

The fast-approaching date for Mr Alner comes after a year of campaigning by family, friends and businesses to raise the £50,000 required for the initial surgery and five-year supplementary treatment using blue shark embryo cells.

The twenty-one year old was injured two years ago when he was pushed into a swimming pool in Majorca, an accident that broke his neck and left him paralysed from the chest down.

"I will make a recovery," he said, and it is this determination that supporters say have helped him to overcome his injury and look to the future.
"It is very rare that you come across someone with such a mature attitude towards life - even with his life having been turned upside down," said friend and key-campaigner Richard Knight.

Mr Knight met Mr Alner through Jayne Patterson another key campaigner for the treatment funds. Mrs Patterson, mother of five, said she heard about the young man in a newspaper article, and having a son the same age, sympathised with him: "I felt compelled to get in touch with Jason to see what I could do to help."
"I went to see him and was absolutely charmed, he is such a nice person," she said.

That was last year, and since then, his mother Maureen McCarthy, Mr Knight and Mrs Patterson have mobilised the local masses and £40,000 of the £50,000 needed has been raised.

Charity events, publicity, auctions, and personal and business donations, including free tickets with Virgin Atlantic, have accumulated to an amount Jason originally thought was impossible to attain.

"It was a bit daunting because of the cost," he says, "It seemed like a longshot instead of a reality."
Mr Alner says the doctors at the International Spinal Cord Regeneration Centre in Tijuana, claim that the treatment has a 98% success rate in giving spinal cord injury patients back some feeling and use of the paralysed limbs.

The doctors say they will first perform surgery on the site of Jason's injury, clearing out anything that may be inhibiting nerve transmission, and reconstruct the spinal canal, a type of surgery that is also being conducted in the United States.

The unorthodox part of the treatment, however, is the introduction at the injury site of shark embryonic fluid. The special embryonic cells, explains centre doctors Wolfram Kuhnau and Fernando Ramirez del Rio, will allow the nerves to regenerate and permit electrical impulses to be transmitted again.
Through physiotherapy and successive injections of the shark embryonic fluid every two weeks for the next five years, Jason has been told he should be able to regain some of his muscular control again.

The head of research at the International Spinal Research Trust, based in Bramley, John Cavanagh, warned that this was unorthodox treatment that was not backed up by published research and was not recognised by the general scientific community.

But Mr Alner said everyone who has participated in the treatment has progressed. Patients with similar injuries to his, he says, have at least recovered use of their hands, he added.

"I could be fully independent," said Jason, who currently requires the assistance of a full time carer.
"What I would do without a doubt, is to get back into deejaying, that is my passion," he said.
If you would like to help in any way, contact Mr Alner on 01483 859164.

[mahabharata69]

Check this link:
http://mysite.mweb.co.za/residents/bhouston/index.html

What is your opinion on this?
http://sci.rutgers.edu/forum/images/smilies/confused.gif Would you consider these facts trustworthy? Could someone be faking the whole thing in order to make publicity to ISCRC institution?

Damir

[giambjj]

These facilites around the US, Mexico, and Canada are restoring the use of hands, fingers, and legs through implanting of electrodes in various muscles, along with tendon tranfers in children less than 21 years of age. http://sci.rutgers.edu/forum/images/smilies/smile.gif

[Wise Young]

There are a number of anecdotal stories like this from Tijuana. At the same time, there are also stories of patients who have not improved. I have met Dr. Ramirez and he is a well-trained neurosurgeon who is experienced with spinal cord surgery. The main problem is that there is little or no evidence that shark embryo transplants do anything.

Wise.

[Steven Edwards]

There are a number of anecdotal stories like this from Tijuana. At the same time, there are also stories of patients who have not improved. Perspective...

[nggun]

Dr. Young,

Thanks for all your time & effort. I think a separate post for these therapies is a great idea and I agree that controversial therapies should be singled out as controversial, and possibly fraudulent. I looked into the shark embryo transplants years ago. They couldn't substantiate their claims and, 10+ years later, still can't. I even showed the information they sent me to my surgeon, (at the time the institute was in Baja, Ca and not Tijuana), and he said the procedure had been advertised for years without any real results.

Noreen

[afkap]

Wise,
My husband (c4/5 incomplete, 12/2000) tried low-dose ketamine infusion for severe neuropathic pain. Still a bit early to say for sure, but one week out, it seems to be helping. For the first time in nearly five years, he has some relief. We hope it continues....

[MichaelLMT]

Stem Cell Surgery In S. Korea (First paralyzed American has stem cell treatment)
WJLA ABC News ^ | November 30, 2005 | Kathy Fowler

Posted on 12/03/2005 8:03:25 PM PST by BlueSky194

A VIRGINIA WOMAN IS RECOVERING FROM A REVOLUTIONARY STEM CELL SURGERY SHE HOPES WILL HELP HER WALK AGAIN.

MICHELLE FARRAR TRAVELED TO SOUTH KOREA - TO BECOME ONLY THE 7TH PERSON IN THE WORLD TO HAVE THIS PROCEDURE.

MEDICAL REPORTER KATHY FOWER WAS WITH HER - AND HAS THIS REPORT FROM SEOUL.

Story: MINUTES BEFORE THE SURGERY THAT MAY MAKE MEDICAL HISTORY....MICHELLE FARRAR, FROM LEESBURG VIRGINIA IS COMFORTED BY HER SISTER'S SONG AND PRAYERS OF HER SOUTH KOREAN SURGEON WHO WITH JUST ONE INJECTION, COULD QUIET THE CONTRAVERSY SURROUNDING STEM CELLS AND GIVE HOPE TO SPINAL CORD PATIENTS.

Michelle: (cries) "It's unreal it really is... I've only dreamed of this now that it's here it's unbelievable."

Michelle's Sister: (crying) "It's not a bad cry."

TODAY MICHELLE IS BECOMING THE ONLY AMERICAN TO HAVE THIS STEM CELL TRANSPLANT AND THIS IS THE FIRST TIME THIS EXPERIMENTAL PROCEDURE HAS EVER BEEN TELEVISED. THERE'S A GREAT DEAL OF TENSION IN THE ROOM. SOUTH KOREAN DOCTORS WANT AMERICAN DOCTORS AND THE WORLD TO KNOW ABOUT THEIR PROGRESS.

THESE ARE THE STEM CELLS HARVESTED FROM THE UMBILICAL CORD BLOOD OF NEWBORNS IN ASIA, THAT WILL BE SURGICALLY IMPLANTED INTO MICHELE'S SPINAL CORD.

Doctor: "We use a microscope...(out) spinal cord"

THESE ARE THE VERY DOCTORS WHO REPORTED SUCCESS GETTING A KOREAN WOMAN, PARALYZED FOR 20 YEARS, TO WALK AGAIN. TODAY THEY'RE USING STEM CELLS FROM 2 UMBILICAL CORDS TO BETTER THE CHANCES OF SUCCESS FOR MICHELLE.

Yung-Su Kye, Histostem Co. Ltd. "25- 20 Millon stem cells injected... at the site of michelle's inury."

BEFORE THE SURGERY, MICHELLE FARRAR SAID SHE'S EXCITED ABOUT HER ROLE AS A TRAILBLAZER - SHE'S PASSIONATE ABOUT LETTING OTHER DOCTORS AND PATIENTS KNOW ABOUT THIS IN AMERICAN.

Michelle: "It should be going on in the U.S. It should be going on all over the world. Why can't the U.S. work with Korea because it's been so successful here already? Why aren't they doing it?"

MOST AMERICAN DOCTORS HAVEN'T CONSIDERED UMBILICAL CORD BLOOD STEM CELLS AS THE BEST OPTION TO EXPLORE FOR SPINAL CORD INJURIES... BUT IF MICHELLE'S SURGERY IS SUCCESSFUL... THAT COULD CHANGE.

Michelle: "There is hope. It' s hope for everybody, nobody had hope."

Kathy Fowler: SOUTH KOREAN DOCTORS SAY MICHELLE'S SURGERY WENT JUST AS PLANNED BUT THEY WON'T KNOW FOR WEEKS, EVEN MONTHS IF IT'S REALLY A SUCCESS.

MICHELLE IS COMING BACK TO THE U.S. CHRISTMAS DAY... THE ONLY PRESENT SHE WANTS THIS YEAR IS TO BE ABLE TO WIGGLE HER TOES.

REPORTING FROM SEOUL SOUTH KOREA, KATHY FOWLER ABC-7 NEWS.

[BLUEDOG765]

dear friends,
I wanted to know has anyone used the medication 4-AP if so what is the pros & cons.
Thanks in advance

[SCI-Nurse]

Bluedog, many people on these forums have used 4-AP. You may want to do a search using that as your search term. You are most likely to get responses to questions about it in the Recovery or Care forums.

(KLD)

[glomae]

i know it's been awhile, but are there CLINICAL TRIALS since i was last on post. i have to to admit after chis reeves death i sorta gave up hope. the media seems to be quite on this issue of SCI thrapies, have we been forgotten?

[jnn]

I am very interested in learning about experimental therapies to educate myself as well as keep my hopes up/but I you should 'draw the line' regarding the reasonableness of what to include. Maybe I've missed it here, but I'd also like an update on what Rutgers is doing. Thank you so much.

[GRCJ7]

Dr. Wise Young,

I Live In Mexico City And I Am Also Going To Investigate What´s Happening.

Thank You

Grcj7

[royandjoe]

Dr Young, washington university ST, Louis missouri has a studie going on for arachnoititis with thalidmide.

what do you think about this drug and this trail i have read some bad things on this drug.

what is your input.

[i wont give up] roy :thinking:

[royandjoe]

i was told when i had a ct w/contras or die scan there was a slight untake in my cervical spine that look like authritis.

first in 98 another in2001 both said the same.

and i lost my
work comp case because they said i could have already had congentital problems.

that could have cause my thoratic post traumatic syringomyelia

and not my fall in 2005. :(


[iwont give up] roy

[royandjoe]

Dr Wise Young are you sure that a ct scan with die can not see and up take like authritis.

how could i resarch or what kind of question should i ask the hospital that done the scan.

i need your help doc about this matter.

if the ct scan can not show untake.

could this mean that it was read wrong.

[i wont give up] roy