Driving with Multiple Sclerosis: Can I? Should I?
Osteoporosis and Physical Activity Among NARCOMS ParticipantsClinical Trial, Open for Enrollment: Stem Cell Therapy for Patients With MS Failing Interferon––A Randomized Study
MS is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune-based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e., interferon, copaxone, or mitoxantrone) in patients with inflammatory (relapsing) MS despite treatment with interferon.
Eligibility:
Inclusion Criteria:
1. Age between 18–55, inclusive
2. Diagnosis of MS using Poser criteria of “clinically definite” MS
3. An EDSS of 2.0 to 6.0
4. Inflammatory disease despite primary disease modifying therapy with at
least 4 months of interferon. Inflammatory disease is defined by either MRI
showing adolinium enhancing lesions or clinically as acute relapses treated
with IV solumedrol. Failure is defined as two or more clinical relapses with
documented neurological changes within one year prior to the study. (Note:
Relapses must have required treatment with corticosteroids). Failure may
also be defined as one relapse within the year prior to the study if there is
evidence on MRI of active inflammation (i.e., gadolinium enhancement).
Exclusion Criteria:
1. Any illness that, in the opinion of the investigators, would jeopardize the
ability of the patient to tolerate aggressive chemotherapy.
2. Prior therapy with mitoxantrone.
3. Prior history of malignancy except localized basal cell, squamous skin
cancer or carcinoma in situ of the cervix. Other malignancies for which the
patient is judged to be cured, such as head and neck cancer, or breast
cancer will be considered on an individual basis.
4. Positive pregnancy test.
5. Inability or unwillingness to pursue effective means of birth control.
Effective birth control is defined as 1) refraining from all acts of vaginal
intercourse (abstinence); 2) consistent use of birth control pills; 3)
injectable birth control methods (Depo-Provera, Norplant); 4) tubal
sterilization or male who has undergone a vasectomy; 5) placement of an
IUD (intrauterine devise); or 6) use, with every act of intercourse, of
diaphragm with contraceptive jelly and/or condoms with contraceptive
foam.
6. Failure to willingly accept or comprehend irreversible sterility as a side
effect of therapy.
7. FEV1/FVC < 60% of predicted after bronchodilator therapy (if necessary).
8. DLCO < 50% of predicted.
9. Resting LVEF < 50%.
10. Bilirubin> 2.0mg/dl.
11. Serum Creatinine> 2.0 mg/dl
12. Known hypersensitivity to mouse, rabbit, or E. Coli derived proteins, or to
iron compounds/medications.
13. Presence of metallic objects implanted in the body that would preclude
the ability of the patient to safely have MRI exams.
14. Diagnosis of primary progressive MS.
15. Platelet count < 100,000/ul, WBC < 1,500 cells/mm3.
16. Psychiatric illness, mental deficiency or cognitive dysfunction making
compliance with treatment or informed consent impossible.
17. Active infection except asymptomatic bacteruria.
Procedure/Benefit: To compare the clinical outcomes for patients treated with standard therapy (including interferons, steroids, IVIG and chemotherapy), vs. those who undergo stem cell transplantation.
Information: Kathleen Quigley, RN, BSN, MBA, phone: 312-908-0059
I have secondary progressive MS and have been on betaseron and avonex,each for 5 years. I have not been on any interferion treatment for atleast 5 years.I have been diagnoised for 15 years I am in a wheelchair. I live in Florida. I did not know if I qualify for this trial. I look forward to your response.
Thank you for your time.
Sherry
I was diagnoses with R/R MS and began treatment using BetaSeron in 2003. My diagnosis changed from R/R to secondary progressive in 2005. I continued taking Betaseron. In 2005 I started falling even when using my walker and figured I would soon need to start using a wheelchair. It was at that time that I stopped using BetaSeron. I have not fallen since.
I am no longer on any interferon drug and do no wish to go on any of them.
Would I be eligible for this study?
Hello,
I am very interested in your study. I was diagnosed 5/08 with RR MS. This diagnosis was made with MRI scans and a spinal tap. I have been on Rebif since August of 08 and have had 2 relapses which were treated with Solumed. I am 46 years old and have been in great health until MS. I believe I am within the critiria.
Would you please contact me with more information? Thank you. Regards, Ellen Michaels
Hi,
I was diagnosed with RR MS in 2003 at the age of 43. Have had 2 serious attacks of my MS. The first was when I was diagnosed. Diagnosis was made by MRI and Spinal tap: Oligloconal bands of 16. Thought I was having a stroke with memory and cognition problems, numbness and gait issues. Had 12 lesions in my brain.In Nov 2008 I had a sudden and unexpected exacerbation which landed me in the ER with seizures due to a “giant” lesion in my Right temporal, perietal (?sp) lobe and cortex. Identified by MRI. Am now on Anti-seizure meds. Both attacks required IV Solumedrol. I have been on Rebif 44mg q 3 days since 2003. Will be having repeat MRI w/o contrast and a Sleep deprivation EEG on Mon. 2/9/09.
Thank you for your consideration, Wendy
Hello,
I am 50 years old. I was diagnosed with relapsing remitting MS in 1986. I started on Betaseron for several years, then was placed on Avonex and then again on Betaseron. I was started on Copaxone in 2004.
Naturally, I have had several relapses over the years with solumedrol being the treatment of choice. This January, I completed a 6 mos treatment of Solumedrol, 1 Gm IV per month. I have been followed with MRI’s throughout my course. My original diagnosis was made with an MRI, CSF, bloodwork and an evoked potential. I am followed at an MS neuro science institute. I am an RN, still working, walking with a forearm crutch, but also using a scooter. I have balance issues and my right leg is affected, including foot drop. I am very healthy otherwise. Married with a supportive husband and three grown supportive children, 2 grandchildren. Thank you for your consideration, Pam.
I am a 37 year old female. I have recently been diagnosed with MS. 3 weeks ago. I am currently active and working as a speech therapist in an Arkansas school district and I am the mother of twin 20 month old boys. I would very much like the opportunity to be part of this study and possibly reverse some symptoms and heed progression of this disease. I believe I meet all necessary criteria.
Callie Caldwell
My husband has been in a study for RRMS for a little over two years taking Avonex and Capoxone in combination (although it’s a blind study, side effects indicate he has been on both). He seems to be getting progressively worse however. This past year he has had two exacerbations treated with IV steriods. The last steriod treatment was last week and we’re waiting to see if it results in improvement. If not, his diagnosis may change to secondary progressive. Would he be eligible for your study and is there another website that gives more detail on the program. We live in Richmond VA