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Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease) Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease) Clinical research trials and Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease) medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease). Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease) Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease) clinical trial. Participants oftentimes recieve the finest healthcare available for their Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease) condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease)



Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease)

For Condition: Mucopolysaccharidosis I
Status: Recruiting
Sponsor(s): Fairview University Medical Center ,
Synopsis: OBJECTIVES: I. Determine whether the proposed allogeneic bone marrow or umbilical cord blood transplantation preparative regimen has acceptable rates of engraftment without unacceptable rates of grade III or IV regimen related toxicities, including transplant related deaths in patients with mucopolysaccharidosis I (Hurler disease).
Details: PROTOCOL OUTLINE: Patients receive oral busulfan every 6 hours on days -9 to -6, cyclophosphamide IV over 2 hours on days -5 to -3, anti-thymocyte globulin IV and methylprednisolone IV every 12 hours on days -3 to -1. Allogeneic bone marrow or umbilical cord blood that has been depleted of T cells is transfused on day 0. Patients receive filgrastim (G-CSF) IV beginning on day 1 and continuing until hematopoietic recovery. After bone marrow transplantation, patients receive graft versus host disease prophylaxis. Patients receive cyclosporine IV on days -3 to 180 and methylprednisolone IV on days 5-56. Both cyclosporine and methylprednisolone are administered orally once tolerable. Patients are followed on days 21, 60, and 100, then at 6 months, 1 year, and then annually thereafter.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of mucopolysaccharidosis I (Hurler disease) with a: HLA identical or haplotype mismatched (at 1-3 antigens) related marrow or umbilical cord blood donor OR HLA identical or HLA-1 antigen mismatched unrelated marrow or umbilical cord blood donor Developmental quotients within 2 standard deviations of normal --Patient Characteristics-- Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: Ejection fraction at least 30% Other: Negative pregnancy test
Total Enrollment: 30

Location and Contact Information:

Overall Study Official:
CharlesPeters,  Study Chair,  Fairview University Medical Center

Fairview University Medical Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Charles  Peters 612-624-5407


Additional Information:
Study ID Numbers:  199/15110;  UMN-MT-1999-07,UMN-MT-9907
Study Start Date: March 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005899

Other Mucopolysaccharidosis I Studies:
1. Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

2. Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Mucopolysaccharidosis I (Hurler Disease)

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