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New treatment option for Crohn's Disease
Official title Autologous Stem Cell Transplantation for Crohn's Disease
ClinicalTrials.gov ID: NCT00692939
What this study is testing
What is autologous CD34-selected peripheral blood stem cells transplant?
autologous CD34-selected peripheral blood stem cells transplant is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crohn's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this study is to evaluate the safety and effectiveness of administering high-dose chemotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC) in pediatric and adult patients with severe Crohn's disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 60
You may be able to join if
- 5.1 1. Subject and/or guardian must be able to understand and provide informed consent.
- Male or female, 10 through 60 years old, inclusive at time of informed consent.
- Examples of people for whom stem cell transplant therapy would be appropriate include, but are not limited to:
- Patients who have had prior surgery and subsequent severe recurrent disease in spite of aggressive maintenance therapy, necessitating consideration...
- Patients who have diffuse small bowel and colonic disease and who are refractory to aggressive medical treatment, and not eligible for treatment...
You likely can't join if
- Patients who have not been treated with adequate dosing of 6-MP, 5-ASA products and metronidazole.
- Patients who achieved a sustained, corticosteroid free response to anti-TNF alpha therapy, anti-integrin therapy or anti-IL12/23 therapy after a 4...
- Toxic megacolon, intestinal perforation
- Conjugated bilirubin \> 2.0 mg/dL.
- Pregnancy or nursing mother
- HIV/HTLV seropositive, HBsAg, or HCV RNA positive by PCR
See the full eligibility criteria
- 5.1 1. Subject and/or guardian must be able to understand and provide informed consent.
- Male or female, 10 through 60 years old, inclusive at time of informed consent.
- Examples of people for whom stem cell transplant therapy would be appropriate include, but are not limited to:
- Patients who have had prior surgery and subsequent severe recurrent disease in spite of aggressive maintenance therapy, necessitating consideration of further extensive surgical resections.
- Patients who have diffuse small bowel and colonic disease and who are refractory to aggressive medical treatment, and not eligible for treatment using a surgical approach without the risk of precipitating short bowel...
- Patients with a persistently high Harvey Bradshaw Index (HBI) (\>6), CDAI (\>250) or Pediatric CD Activity Index (PCDAI\>45) (44) score or those in the lower, moderate range (HBI ≤ 6), (CDAI \< 250), (PCDAI 30-45), but...
- Patients who have resistant complications of CD unresponsive to medical management including multiple enteric fistulas, enterovesicular or enterovaginal fistulas, severe perianal disease, debilitating arthritis, severe...
- Patients who developed severe complications to while receiving medical management such as pancreatitis following 6-Mercaptopurine, colitis following 5-ASA or those with severe hypersensitivity to TNFalpha inhibitors...
- Patients with stomas are eligible.
- No surgical therapeutic option secondary to risk of short bowel syndrome or patient refusal.
- Harvey Bradshaw Index (HBI) or CD activity score \>5, CDAI \>250 or PCDAI \>30.
- Platelet count greater than 100,000/mm3.
- Absolute neutrophil count greater than 1500/mm3 (unless secondary to 6MP therapy).
- Creatinine ≤ 2.0 mg/dL.
- No history of coronary artery disease; resting LVEF ≥ 40% or shortening fraction ≥ 26%.
- FEV1/FVC ≥ 60% predicted for age; DLCO ≥ 60% predicted value for age.
- Negative pregnancy test for females ≥ 10 years old or who have reached menarche, unless surgically sterilized.
- All females or childbearing potential and sexually active males must agree to use a FDA approved method of birth control for up to 24 months after PBSC transplant or for as long as they are taking any medication that...
- Patients who have not been treated with adequate dosing of 6-MP, 5-ASA products and metronidazole.
- Patients who achieved a sustained, corticosteroid free response to anti-TNF alpha therapy, anti-integrin therapy or anti-IL12/23 therapy after a 4 month course of treatment.
- Toxic megacolon, intestinal perforation
- Conjugated bilirubin \> 2.0 mg/dL.
- Pregnancy or nursing mother
- HIV/HTLV seropositive, HBsAg, or HCV RNA positive by PCR
- Active infection, as determined by the appropriate confirmatory testing e.g. blood cultures, PCR testing, etc., within two weeks of mobilization and high dose chemotherapy.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.