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Autologous Stem Cell Transplant for Crohn’s Disease

September 12, 2019

Overview

Although frequently ineffective, immune cell suppression therapy is widely used to treat Crohn’s disease, an inflammatory bowel disease. Hematopoietic stem cell transplantation (HCT) is an alternative procedure to treat Crohn’s disease. Researchers at Icahn School of Medicine at Mount Sinai are researching the combined use of HCT and the drug vedolizumab to improve remission of CD for patients.

 

Study Information

Study admission is granted to patients where surgery is not an option and the disease does not respond to the following treatments:

  • corticosteroids
  • azathioprine, 6-mercaptopurine, methotrexate
  • Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)
  • Anti-integrin agents

If granted admission, patients will be hospitalized for 1-2 weeks. They will undergo the stem cell transplant with high dose chemotherapy and given vedolizumab after. The entire process will be administered as:

  • Procedure: Autologous stem cell transplant
  • Drug: Cyclophosphamide
  • Drug: Thymoglobulin
  • Drug: Methylprednisolone
  • Drug: Vedolizumab

 

Inclusion Criteria

  • Diagnosed with Crohn’s disease
  • Disease is active, rather than in remission, based on clinical symptoms
  • Disease is active, rather than in remission, based on endoscopic evaluation
  • Does not respond to the classes of drugs listed below:
    1. corticosteroids
    2. azathioprine,
    3. 6-mercaptopurine, methotrexate
    4. Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)
    5. Anti-integrin agents (natalizumab, vedolizumab)
    6. Ustekinumab
  • Cannot undergo surgery.

 

Exclusion Criteria

  • All sexes, ages 18 and older
  • Unable to take the following medications: cyclophosphamide, thymoglobulin, vedolizumab
  • Pregnant or breastfeeding
  • Healthiness defined by a Karnofsky Performance Score less than 60
  • Patients with an infection for at least one month
  • Patients with symptomatic coronary artery disease or uncontrolled congestive heart failure.
  • HIV infected
  • Ejection fraction less than 30% or requiring supplemental continuous oxygen.
  • Diffusing capacity of lung for carbon monoxide less than 35% or requiring supplementary oxygen.
  • Patients with an insufficient number of stem cells (<2 X 10^6/kg).

 

Locations

You may participate in this study at the Icahn School of Medicine at Mount Sinai in New York, New York, United States, 10029. Feel free to contact Artur Shchukin at 212-241-0497 or at artur.shchukin@mssm.edu.

 

Sponsors/Collaborators

This clinical trial is sponsored by the Icahn School of Medicine at Mount Sinai with Amir Steinberg, MD and Louis Cohen, MD serving as the Principal Investigators.

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