Pittsburgh, PANCT00692939Now EnrollingIRB Ready

Crohn's Disease Clinical Trial in Pittsburgh, PA

Access cutting-edge crohn's disease treatment through this phase 1/2 clinical trial at a research site in Pittsburgh. Study-provided care at no cost to qualified participants.

Sponsored by Paul Szabolcs

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Expert Care in Pittsburgh

Access crohn's disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related crohn's disease treatment provided free

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Check if you qualify for this crohn's disease clinical trial in Pittsburgh, PA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Pittsburgh

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Pittsburgh site if eligible
  4. 4Begin participation

About This Crohn's Disease Study in Pittsburgh

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.

Sponsor: Paul Szabolcs

Who Can Participate

Inclusion Criteria

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 subjects 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 syndrome and dependence of parenteral nutrition or who have other conditions that preclude surgery
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 who are dependent on daily doses of corticosteroids, that are unable to be withdrawn, and aggressive medical treatment to maintain moderate disease status.
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 skin lesions (pyoderma), and severe bony complications of the disease and therapy (aseptic necrosis, pathologic fractures).
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 (infliximab, adalimumab, certolizumab pegol), anti-integrin agents (natalizumab, vedolizumab) or anti-IL12/23 agents (ustekinumab).
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 may harm a pregnancy, an unborn child or may cause a birth defect. 5.2

Exclusion Criteria

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 study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT00692939) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Crohn's Disease Treatment Options in Pittsburgh, PA

If you're searching for crohn's disease treatment options in Pittsburgh, PA, this clinical trial (NCT00692939) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced crohn's disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all crohn's disease clinical trials near you to find additional studies recruiting in your area.

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