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Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency Clinical research trials and Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency. Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency clinical trial. Human subjects often receive the most effective healthcare possible for their Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency



Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency

For Condition: Leukocyte Adhesion Deficiency Syndrome
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , Children's Hospital and Medical Center - Seattle
Synopsis: OBJECTIVES: I. Investigate the efficiency and safety of transducing the human CD18 DNA into filgrastim (G-CSF) mobilized, CD34 enriched peripheral blood repopulating cells from patients with a severe or moderate deficiency form of leukocyte adherence deficiency (LAD) by retrovirus-mediated gene transfer. II. Investigate whether the human CD18 cDNA is expressed sufficiently to benefit patients with this disease. III. Determine whether repeated infusions of transduced peripheral blood repopulating cells increase the number of surface CD11/CD18 positive cells in these patients. IV. Determine the extent of long-term persistence of transduced peripheral blood repopulating cells in LAD patients not receiving prior myeloablation.
Details: PROTOCOL OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily on days 1-5 with peripheral blood cell collections on days 4 and 5. Patients receive infusions of transduced CD34+ peripheral blood cells on day 8. Patients may be offered a second course of transduced peripheral blood cells for a total of 4 infusions. Patients are followed monthly for one year and then annually for 4 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 4 Years/65 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Leukocyte adherence deficiency (LAD): Severe or moderate deficiency LAD disease confirmed by surface immunofluorescence of peripheral blood leukocytes of less than 10% normal Measurable clinical disease in the form of at least one episode of life-threatening disease Allogeneic bone marrow transplantation offered if HLA-matched sibling donor available --Patient Characteristics-- Performance status: Karnofsky 60-100% Hematopoietic: WBC greater than 2,000/mm3; Absolute neutrophil count greater than 1,000/mm3; Platelet count greater than 50,000/mm3; Prothrombin time and partial thromboplastin time less than 1.5 times upper limit of normal (ULN) Hepatic: Bilirubin no greater than 2.5 mg/dL; SGOT and SGPT no greater than 5 times ULN; Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: Normal cardiac function Pulmonary: No cardiorespiratory instability Other: Triglycerides less than 400 mg/dL; Amylase no greater than 1.5 times ULN; HIV negative; No acute infection; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment: 4

Location and Contact Information:

Overall Study Official:
DennisHickstein,  Study Chair,  Children's Hospital and Medical Center - Seattle


Additional Information:
Study ID Numbers:  199/13939;  CHMC-S-IRB-198-99-07,CHMC-S-DK47754,CHMC-S-HL54881,CHMC-S-IRB-207-9708,CHMC-S-IRB-216-00-07,FHCRC-981,NIH/ORDA-9707-204,UWASH-198-99-07,UWASH-207-9708
Study Start Date: October 1999
Record last reviewed: May 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004470

Other Leukocyte Adhesion Deficiency Syndrome Studies:
1. Interferon Gamma to Treat Leukocyte Adhesion Deficiency Type I

2. Gene Therapy for Patients with Leukocyte Adherence Deficiency (Follow-Up of Phase 1 Trial)

3. Use of G-CSF to Obtain Blood Cell Precursors

4. Phase I Study of Retrovirus-Mediated Transfer of cDNA for Human CD18 into Peripheral Blood Repopulating Cells of Patients With Leukocyte Adherence Deficiency

5. Study of Genetic and Molecular Defects in Primary Immunodeficiency Disorders

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