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Stem Cell Transplant to Treat Patients with Systemic Sclerosis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Stem Cell Transplant to Treat Patients with Systemic Sclerosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Stem Cell Transplant to Treat Patients with Systemic Sclerosis Clinical research trials and Stem Cell Transplant to Treat Patients with Systemic Sclerosis health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Stem Cell Transplant to Treat Patients with Systemic Sclerosis. Stem Cell Transplant to Treat Patients with Systemic Sclerosis Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Stem Cell Transplant to Treat Patients with Systemic Sclerosis clinical trial. Test subjects typically receive the most expert healthcare available for their Stem Cell Transplant to Treat Patients with Systemic Sclerosis condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Stem Cell Transplant to Treat Patients with Systemic Sclerosis  Stem Cell Transplant to Treat Patients with Systemic Sclerosis
Stem Cell Transplant to Treat Patients with Systemic Sclerosis
For Condition: Systemic Sclerosis
Status: Recruiting
Sponsor(s): Baylor College of Medicine , The Methodist Hospital
Synopsis: Systemic Sclerosis is a disease that may be caused by the immune system reacting against skin and certain organs. It is possible, that by changing the immune system we can modify the progression of this disease. Stem cells are created in the bone marrow. They mature into different types of blood cells that are needed including red blood cells, white blood cells, and platelets. In this study, we will stimulate the bone marrow to make extra stem cells. Next we will collect the stem cells, select specific cells, and store them. We will then give high dose chemotherapy that will destroy the patients immune system. We will then give back the selected stem cells we collected. We believe that these selected stem cells may be able to "re-create" the immune system without the portion that causes Systemic Sclerosis. The purpose of this study is to try to discover if stem cell transplantation can help patients with Systemic Sclerosis. We will also try to learn what the side effects are of this treatment in patients with Systemic Sclerosis. We hope that this treatment will help to relieve the symptoms patients are experiencing, although we do not know if it will.
Details: Before the transplant the research participant will receive daily G-CSF (Neupogen) for 5-6 days. This medication will help to stimulate the production of white blood cells (WBC) that will be used for the stem cell transplant. The G-CSF will be given as an injection into the arm. If G-CSF does not stimulate the stem cells sufficiently, the patient will receive a single dose of drug called cyclophosphamide (chemotherapy) intravenously (into a vein). This drug will cause the blood cell counts to fall. A drug called MESNA will also be given to help protect the bladder from the Cyclophosphamide. After completing chemotherapy, patients will be started on G-CSF again until blood cell counts reach a certain level, at which time the patient will undergo leukopheresis. Leukopheresis is a procedure where blood is removed from one arm, pumped into a machine where the white blood cells are separated from most of the other cells and then returned through the same needle or through a needle in the other arm. This procedure usually takes 3 to 4 hours a day for up to 4 days in a row, depending on how many cells are collected each time. After collection of the white blood cells, special agents (called monoclonal antibodies) will be used in the laboratory to select out certain types of white blood cells (CD34+ cells). The blood cells will be separated on a machine which picks out stem cells. After leukopheresis, patients will receive drugs called cyclophosphamide and Mesna. They will also receive a drug called Atgam and radiation treatment to the entire body. This treatment will kill most of the blood forming cells in the bone marrow. We will then give the CD34+ cells that were collected during leukopheresis. After the transplant patients will be followed closely, the same as any patient who receives a stem cell transplant. This follow-up will involve blood tests to see how the body is recovering after the chemotherapy and radiation, and a bone marrow aspiration once a year for 2 years.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Eligibility Criteria: - Patients aged < 60 years - Patients must have either one major or 2 minor criteria for systemic sclerosis as per the criteria developed during the Scleroderma Criteria Cooperative Study. - Rapidly progressive diffuse skin disease without other organ involvement (at least one of the following): - Scl-70 positive - Rodnam Skin score 16 - With/without U3RNP antibodies; RNA polymerases 1-111 OR - Internal Organ Involvement (at least one of the following): - Renal Proteinuria > 500mg/dl - Creatinine clearance > 50ml/min. - Blood pressure controlled to 160/110 - Interstitial lung disease on high resolution CT - Hypoxemia (pO2 > 70 mmHg) - FVC > 50% - DLCO > 45% - Cardiac Disease - Myocarditis - Pericarditis - Coronary Artery Ejection Fraction > 30% - Patients must meet the following hematological parameters: - Have an ANC > 500/mm3 - Have a platelet count > 120 x lO9/l - Have a hemoglobin > 10g/dl Exclusion Criteria: - Patients > 60 years - Patients with pulmonary, cardiac, hepatic, or renal impairment which would limit their ability to receive cytoreductive therapy and compromise their survival. This should include patients with any of the following: - Severe Lung Disease - Hypoxemia (pO2 £70 mmHg) - FVC of < 50% - DLCO of < 45% - Cardiac Disease - Ejection fraction < 30% - Uncontrolled arrhythmias - Cor. Pulmonale - Pulmonary hypertension (mPAP >/=60 mmHg) - Loss of digits or vascular access secondary to Raynaud’s ischemia - History of oliguric renal failure or episode of renal crisiswith Glomerular filtration rate < 50ml/min Creatinine. Weight loss > 20% baseline since first involvement of gastrointestinal tract (midgut); or any patient requiring hyperalimentation prior to transplant because of gut dysfunction related to systemic sclerosis - SGOT/bilirubin > 2 x UPN on 2 repeated tests - Has active uncontrolled infection - Is sero-positive for HIV - Has demonstrated lack of compliance with prior medical care - Has active malignancy - Life expectancy is severely limited by illness other than scleroderma - Has evidence of myelodysplasia or prior extensive chemotherapy - Has uncontrolled hypertension - Positive pregnancy test
Total Enrollment: 24
Location and Contact Information:
The Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Malcolm Brenner 832-824-4668
Additional Information:
Study ID Numbers: H7157; Systemic Sclerosis
Study Start Date: June 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058578
Other Systemic Sclerosis Studies:
1. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
2. Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
3. Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis
4. Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
5. Scleroderma Registry
Related Studies:
Other Systemic Sclerosis Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Stem Cell Transplant to Treat Patients with Systemic Sclerosis
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