Actively Recruiting
Autologous Stem Cell Transplantation for Crohn's Disease
Led by Paul Szabolcs · Updated on 2025-12-15
20
Participants Needed
2
Research Sites
805 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous Stem Cell Transplantation for Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Patients with prior surgery and severe recurrent Crohn's disease despite aggressive therapy.
- Patients with diffuse small bowel and colonic disease refractory to medical treatment and unsuitable for surgery.
- Patients with a persistently high Harvey Bradshaw Index (>6), CDAI (>250), or PCDAI (>45), or moderate disease dependent on corticosteroids.
- Patients with resistant Crohn's complications unresponsive to medical management, including multiple fistulas, severe perianal disease, arthritis, severe skin lesions, or bony complications.
- Patients with severe complications from medical treatments such as pancreatitis or hypersensitivity to certain medications.
- Patients with stomas are eligible.
- No surgical option due to risk or patient refusal.
- Platelet count >100,000/mm3.
- Absolute neutrophil count >1500/mm3 (unless due to 6MP therapy).
- Creatinine ≤ 2.0 mg/dL.
- No history of coronary artery disease; resting LVEF ≥40% or shortening fraction ≥26%.
- Lung function: FEV1/FVC ≥60% predicted; DLCO ≥60% predicted.
- Negative pregnancy test for females ≥10 years or post-menarche unless surgically sterile.
- Agreement to use FDA approved birth control for up to 24 months after transplant or during harmful medication use.
You will not qualify if you...
- Patients not treated with adequate dosing of 6-MP, 5-ASA products, and metronidazole.
- Patients with sustained corticosteroid-free response to anti-TNF alpha, anti-integrin, or anti-IL12/23 therapy after 4 months.
- Toxic megacolon or intestinal perforation.
- Conjugated bilirubin >2.0 mg/dL.
- Pregnancy or nursing.
- HIV/HTLV seropositive, HBsAg, or HCV RNA positive.
- Active infection within two weeks of mobilization and chemotherapy.
- Medical problems that pose additional risks, interfere with study compliance, or affect data quality as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UPMC Prebyterian- Adult Gastroenterology
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
2
Children's Hospital of Pittsburgh of UPMC-Bone Marrow Team
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
S
Shawna H McIntyre, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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