Hematopoietic Stem Cell Therapy for Patients With Multiple Sclerosis - Full Text View

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00278655

Purpose

Multiple sclerosis is disease believed to be due to immune cells, cells which normally protect the body, but are now attacking the tissue in the brain and possibly the spinal cord. The likelihood of progression of this disease is high. This study is designed to examine whether treating patients with high dose cyclophosphamide and CAMPATH-1H (drugs which reduce the function of the immune system) followed by return of previously collected blood stem cells will stop the progression of your multiple sclerosis. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the cyclophosphamide and CAMPATH-1H is to destroy the cells in your immune system which are thought to be causing your disease. The purpose of the stem cell infusion is to restore the body's blood production, which will be severely impaired by the high dose chemotherapy and to produce a normal immune system that will no longer attack the body.

Condition	Intervention	Phase
Multiple Sclerosis	Procedure: hematopoietic stem cell transplantation	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Interferon Therapy: A Phase II Multi-Center Trial

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Disease progression, defined as a 1 point increase in the EDSS on consecutive evaluations at least 3 months apart; Survival;Twenty-five meter timed; Nine hole PEG test ambulation; MRI enhancing lesions and T2 burden of disease [ Time Frame: 5 years after transplant ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	June 2003
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

stem cell

Autologous hematopoietic stem cell transplantation

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18-50, inclusive.
Diagnosis of MS using Poser criteria (Appendix A).
An EDSS of 2.0 - 5.5 (Appendix B).
Inflammatory disease despite primary disease modifying therapy with at least 3 months of interferon. Failure is defined as two or more clinical relapses with documented neurologic changes within the year prior to the study. (NOTE: Relapses must have required treatment with corticosteroids. Sensory only relapses are excluded.) Failure may also be defined as one relapse within the year prior to study if there is evidence on MRI of active inflammation (i.e., gadolinium enhancement).

Exclusion Criteria:

Any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy.
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.
Positive pregnancy test.
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 partner who has undergone vasectomy; 5) placement of an IUD (intrauterine device); or 6) use, with every act of intercourse, of diaphragm with contraceptive jelly and/or condoms with contraceptive foam.
Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
FEV1/FVC < 60% of predicted after bronchodilator therapy (if necessary).
DLCO < 50% of predicted.
Resting LVEF < 50 %.
Bilirubin > 2.0 mg/dl.
Serum creatinine > 2.0 mg/dl.
Known hypersensitivity to mouse, rabbit, or E. Coli derived proteins, or to iron compounds/medications.
Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have MRI exams.
Diagnosis of primary progressive MS.
Platelet count < 100,000/ul.
Psychiatric illness, mental deficiency or cognitive dysfunction making compliance with treatment or informed consent impossible.
Active infection except asymptomatic bacteruria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278655

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Richard Burt, MD

Northwestern University

More Information

No publications provided

Responsible Party:	Northwestern University ( Richard Burt, MD )
ClinicalTrials.gov Identifier:	NCT00278655 History of Changes
Other Study ID Numbers:	DIAD MS.Auto2002
Study First Received:	January 16, 2006
Last Updated:	July 1, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 01, 2010