Actively Recruiting
Stem Cell Transplantation in Crohn's Disease
Led by Cedars-Sinai Medical Center · Updated on 2026-02-20
15
Participants Needed
1
Research Sites
410 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Unfortunately, some patients with Crohn's disease (CD) fail to respond to the best clinical treatments and some only experience temporary benefit. For severe Crohn's disease, there is an experimental treatment called "high dose immunoablation" followed by autologous hematopoietic stem cell transplantation (HSCT). This study removes over active lymphocytes (immunoablation) and replaces them using blood stem cells that have been taken from the patient's own body. The aim of the study is to reset or reprogram the patient's immune system to its state prior to diagnosis.
CONDITIONS
Official Title
Stem Cell Transplantation in Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 13 to 28 years
- Confirmed diagnosis of active Crohn's disease with typical radiological or histological evidence at least 6 months before screening
- Active disease at registration defined by PCDAI > 30 and two of the following: elevated CRP, endoscopic evidence of active disease with histology confirmation, or active small bowel Crohn's disease on CT or MR enterography
- Unsatisfactory response or intolerance to three immunosuppressive agents including azathioprine, methotrexate, infliximab, adalimumab, and/or certolizumab, plus corticosteroids
- Current problems unsuitable for surgery or risk of short bowel syndrome
- Accepted by the combined IBD Center as appropriate candidate
- Provided informed consent and prepared for additional study procedures after counseling about risks
You will not qualify if you...
- Pregnancy or unwillingness to use adequate contraception for women of childbearing age and males
- Severe kidney disease with creatinine clearance below 30 mL/min
- Severe heart conditions including refractory congestive heart failure, low ejection fraction, chronic atrial fibrillation requiring anticoagulation, uncontrolled arrhythmia, or hemodynamic pericardial effusion
- Severe lung impairment with diffusion capacity below 40%
- Active psychiatric disorders including drug or alcohol abuse
- History or current malignancy except non-melanoma skin cancer
- Uncontrolled hypertension despite at least two medications
- Infection with HIV, HTLV-1 or 2, hepatitis viruses, or other infections contraindicating participation
- Other chronic diseases causing significant organ failure
- Current relevant abscess or significant active infection
- Perianal fistula without free drainage unless seton suture present
- History or risk of tuberculosis or abnormal chest X-ray indicating active infection or neoplasm
- Significant malnutrition defined as BMI ≤ 18 or serum albumin < 20 g/l
- Previous poor compliance
- Participation in other investigational drug or hematopoietic growth factor protocols within four weeks before entry
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
D
David Ziring, MD
CONTACT
Y
Yvette Gonzales, MBA
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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