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Autologous Transplantation for Multiple Sclerosis
N/A
Waitlist Available
Led By David J Hermel, MD
Research Sponsored by Scripps Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time to first confirmed acute relapse or 5 years after treatment which ever comes first
Awards & highlights
Study Summary
This trial is comparing two different ways of using chemotherapy and proteins that target immune cells to treat relapsing remitting multiple sclerosis.
Eligible Conditions
- Multiple Sclerosis, Relapsing-Remitting
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation of study to completion, up until 5 years after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of study to completion, up until 5 years after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Durability of remission between two arms
Secondary outcome measures
Neurologic Disability
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cyclophosphamide/Rituximab Conditioning RegimenExperimental Treatment2 Interventions
Cyclophosphamide (200 mg/kg) / rituximab (1000 mg).
Group II: Cyclophosphamide/ATG Conditioning RegimenExperimental Treatment2 Interventions
Cyclophosphamide (200 mg /kg) / rabbit antithymocyte globulin (6.0 mg/kg)
Find a Location
Who is running the clinical trial?
Scripps HealthLead Sponsor
54 Previous Clinical Trials
11,792 Total Patients Enrolled
David J Hermel, MDPrincipal InvestigatorScripps Health
James R Mason, MDPrincipal InvestigatorScripps Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You haven't taken dimethyl fumarate (Tecfidera) for at least 3 months before the hematopoietic stem cell transplant.You are between 18 and 58 years old.You have primary progressive multiple sclerosis.You have developed new lesions in your brain since you were diagnosed.You have certain types of lesions in specific areas of your brain or spine as shown on an MRI scan.You have not taken natalizumab for at least 5 months before the HSCT procedure.You must not have taken rituximab or ocrelizumab for at least 5 months before the hematopoietic stem cell transplantation (HSCT).You must not have taken fingolimod for at least 3 months before the HSCT.If you previously took teriflunomide and it didn't work, your blood levels of the drug need to be very low even after taking certain medicines to help clear it from your body.You have used mitoxantrone before.You have previously taken cladribine.You have not had any new or growing lesions in the past year.You have stiffness in your legs unless there is evidence of new MRI changes in the past year.Your liver function test shows high levels of AST or ALT, or bilirubin levels are too high.Your lung function is significantly reduced, or you have asthma that is difficult to manage with medication, or you have high blood pressure in the arteries of your lungs.You have a certain type of multiple sclerosis and have experienced a specific number of MS flares within a certain time period, or have certain types of brain lesions.You have other immune-related neurological diseases like neuromyelitis optica (NMO), chronic inflammatory demyelinating polyneuropathy (CIDP), Stiff person syndrome, or myasthenia gravis.You have thalassemia major.You have had or currently have any cancer except for certain types of skin cancer that have been completely removed.You cannot have received alemtuzumab for 12 months before the hematopoietic stem cell transplant.You have a blood clotting disorder, are taking blood thinners, have low platelet count, or have myelodysplastic syndrome.You have optic neuritis without any other related conditions.You have been diagnosed with certain autoimmune diseases, except for thyroid issues or certain blood disorders that are under control.You rely on insulin to manage your diabetes.You have porphyria.You had a heart attack in the past year, or have ongoing heart rhythm problems that are not well controlled with medication. If you need medication for a heart rhythm problem, it must be approved by a heart doctor.You have HIV, hepatitis B, hepatitis C, or a positive tuberculosis test, or you have an active infection at the time of hospital admission (except for a urinary tract infection).Your disability level, measured by the EDSS score, is less than 2.0 when you join the study or submit your insurance.You have genetic neurological conditions like Charcot-Marie-Tooth disease or spinal cerebellar degeneration.The participant has a clinically isolated lesion.You have overactive reflexes or repetitive, involuntary muscle contractions.Your kidney function is not good, with high levels of creatinine in your blood or having nephrotic syndrome.You have sickle cell disease.You do not understand that infertility can happen as a result of the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cyclophosphamide/Rituximab Conditioning Regimen
- Group 2: Cyclophosphamide/ATG Conditioning Regimen
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to register for this clinical experiment?
"This clinical trial is accepting 200 adults between 18 and 58 who have been diagnosed with acute relapsing multiple sclerosis. Furthermore, they must meet the following criteria: MRI T2 hyperintense lesions in two or more of the specified locations; new gadolinium-positive lesion since diagnosis; 2 or more active flares despite treatment in 12 months prior to study entry; Active secondary progressive MS (aSPMS) with at least one enhancing lesion > 5mm within 9 months of study start."
Answered by AI
Is it still feasible for those interested to join this clinical trial?
"According to the latest records hosted on clinicaltrials.gov, this medical trial is still enrolling participants and was initially posted in January of 2023 with its last edit taking place on November 18th 2022."
Answered by AI
Does this clinical trial extend to geriatric populations?
"The age parameters for this medical trial are 18 - 58 years old."
Answered by AI
How many subjects are partaking in this experiment?
"Affirmative. As outlined on clinicaltrials.gov, this medical investigation is currently seeking participants and was originally posted on January 1st 2023 before being updated November 18th 2022. 200 patients are needed from a singular location to be involved in the trial."
Answered by AI
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