- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001398
Stem Cell Factor Medication for Aplastic Anemia
A Phase I/II Trial of Recombinant Methionyl Human Stem Cell Factor (r-metHuSCF) in Patients Diagnosed With Acquired Aplastic Anemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Heart, Lung and Blood Institute (NHLBI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Acquired moderate or severe aplastic anemia.
Intolerant to, or failure to durably respond to, ATG/ALG therapy with or without cyclosporin.
Patients may not have received ATG/ALG, therapy for 12 weeks prior to enrollment or cyclosporin for 4 weeks prior to enrollment.
Two years of age or older.
Karnofsky Performance Status greater than or equal to 60 percent.
Adequate organ function as defined by serum creatine less than 2.0 mg/dl and a bilirubin less than 2.0 mg/dl.
Patients (or their parent[s]/responsible guardian[s]) must be able to comprehend and be willing to sign an informed consent prior to starting r-metHuSCF therapy.
No current diagnosis or past history of myelodysplastic syndromes.
No diagnosis of Fanconi's anemia, dyskeratosis congenita, or other congenital forms of aplastic anemia.
No current diagnosis of clinically active paroxysmal nocturnal hemoglobinuria (PNH) defined as patients with clinically significant thrombosis or hemolysis.
No diagnosis of eosinophilic fasciitis.
No treatment with ATG, ALG, or other immunosuppresive agents within 12 weeks of enrollment or treatment with cyclosporine A or IL-3 within 4 weeks of enrollment.
No treatment with hematopoietic growth factors within 2 weeks of enrollment.
No evidence of active uncontrolled infection.
No known allergy to Ecoli-derived products.
No current or recent symptoms of asthma occurring within the past 10 years (including allergic asthma, or asthma induced by cold temperature, infection, or exercise).
No history of anaphylactic/anaphylactoid-type event manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm (or for example: food, insect bites, etc). Patients with drug allergies, manifested solely by rash and/or urticaria, are not excluded. An isolated episode of urticaria occuring more than 3 years earlier is not a contraindication.
No significant nonmalignant disease including previously documented HIV infection, uncontrolled hypertension (diastolic blood pressure greater than 115 mmHg), unstable angina, congestive heart failure (greater than NY Class II), poorly controlled diabetes, coronary angioplasty within 6 months, or uncontrolled atrial or ventricular cardiac arrhythmias.
No pregnancy or breast feeding. Those of childbearing potential must observe adequate birth control measures.
No treatment with an investigational agent (other than hematopoietic growth factors) within 4 weeks of study entry.
No concurrent use of beta adrenergic blocking agents.
No concurrent use, or use within the past 2 weeks, of Monoamine Oxidase Inhibitors (MAO Inhibitors).
No psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Publications and helpful links
General Publications
- Camitta BM, Thomas ED, Nathan DG, Gale RP, Kopecky KJ, Rappeport JM, Santos G, Gordon-Smith EC, Storb R. A prospective study of androgens and bone marrow transplantation for treatment of severe aplastic anemia. Blood. 1979 Mar;53(3):504-14. No abstract available.
- Camitta BM, Storb R, Thomas ED. Aplastic anemia (first of two parts): pathogenesis, diagnosis, treatment, and prognosis. N Engl J Med. 1982 Mar 18;306(11):645-52. doi: 10.1056/NEJM198203183061105. No abstract available.
- Szklo M, Sensenbrenner L, Markowitz J, Weida S, Warm S, Linet M. Incidence of aplastic anemia in metropolitan Baltimore: a population-based study. Blood. 1985 Jul;66(1):115-9.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 940016
- 94-H-0016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancytopenia
-
Shanghai Children's Medical CenterXiamen Amoytop Biotech Co., Ltd.CompletedPancytopenia Due to ChemotherapyChina
-
University Hospital, CaenCompleted
-
National Heart, Lung, and Blood Institute (NHLBI)Completed
-
Qianfoshan HospitalChinese Medical AssociationRecruiting
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedHematologic Diseases | Anemia, Aplastic | Pancytopenia | Blood Disease
-
Elixirgen Therapeutics, Inc.RecruitingBone Marrow Failure | Telomere ShorteningUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)Completed
-
Elixirgen Therapeutics, Inc.Not yet recruiting
Clinical Trials on Recombinant Methionyl Human Stem Cell Factor (r-metHuSCF)
-
National Institute of Diabetes and Digestive and...CompletedSickle Cell Anemia | Hemoglobin SC DiseaseUnited States
-
National Center for Research Resources (NCRR)Completed
-
University of MiamiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of MiamiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Merck KGaA, Darmstadt, GermanyCompletedInfertility Implantation Failure
-
Merck KGaA, Darmstadt, GermanyCompletedInfertility Implantation Failure
-
University of Texas Southwestern Medical CenterCompletedInsulin Resistance | Partial Lipodystrophy | Generalized Lipodystrophy | HypoleptinemiaUnited States
-
Rockefeller UniversityColumbia University; Weill Medical College of Cornell University; St. Luke's-Roosevelt...Completed
-
Eastern Cooperative Oncology GroupNational Cancer Institute (NCI)CompletedMyelodysplastic Syndromes | AnemiaUnited States
-
EMD SeronoTerminatedArthritis, PsoriaticUnited States, Canada