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MUSC Stromal Cell Therapy Study
Study Title:
A phase II-controlled trial of human allogeneic umbilical cord-derived mesenchymal stromal cells (MSCs) for the Treatment of Refractory Lupus.
Sponsor Name:
Medical University of South Carolina with funding for this trial comes from the Lupus Foundation of America and the National Institutes of Health.
Purpose of Study:
What is the treatment? The treatment consists of mesenchymal stromal cells (MSCs) that come from umbilical cords. The cells are made at the Clean Cell Facility at the Medical University of South Carolina. It is believed these cells can correct some of the immune system problems that cause lupus. Participants will either receive a dose of 5,000,000 stromal cells or placebo. The treatment is a one-time infusion that takes approximately half an hour. This trial is approved by the FDA and the Institutional Review Board.
Before you choose to participate, you should speak with your doctor.
What are the criteria for participating?
- You are between the ages of 18 and 65 years old, male or female, of any race
- Your lupus is moderately active as judged by your rheumatologist despite your being on immunosuppressive therapy.
- These immunosuppressive therapies can include medications such as azathioprine (Imuran), leflunomide (Arava), methotrexate (Rheumatrex) and mycophenolate (CellCept) among others. If you are receiving biologics, such as belimumab (Benlysta) or rituximab (Rituxan), you may have to stop these drugs prior to entering the study. Tapering prednisone to 10 mg/day or less is also one of the goals of the trial.
How many study visits are there? There are 12 study visits over 1 year to allow the study doctors to assess how you are doing. All participants will continue the medications they were on at the time they enter the trial.
Study Type:
- Phase 2, randomized, double-blind, placebo controlled, multicenter
Safety of the participants is the most important consideration in this trial. While hundreds of patients have safely received these cells for a variety of other diseases, some participants want to know how the study team will react if their lupus symptoms become more active during the study. There may be a period of time when your lupus symptoms do become more active. If this occurs, you and your doctor can change your medications, for example, by introducing a new dose of prednisone, if it is felt the activity of your lupus warrants it. All treatment programs include standard of care for your lupus including drugs such as Plaquenil, prednisone and immunosuppressants such as azathioprine and mycophenolate.
There is no charge for the study treatment, lab tests or evaluations. Compensation is provided to help offset costs related to your time and travel.
Contact the site closest to you to learn more!
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Contact: Marianne Bernardo | 310-423-3032 | Marianne.Bernardo@cshs.org
Principal Investigator: Mariko L. Ishimori, MD
University of California - San Diego
San Diego, California, United States, 92093
Contact: Erica Brodie | 858-246-2386 | ebrodie@health.ucsd.edu
Principal Investigator: Kenneth Kalunian, MD
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Contact: Karla Caylor, RN | 404-616-7553 | kcaylor@emory.edu
Principal Investigator: S. Sam Lim, MD, MPH
Sub-Investigator: Arezou Khosroshahi, MD
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Contact: Komel Safdar |312-503-0251 | komel.safdar@northwestern.edu
Principal Investigator: Rosalind Ramsey-Goldman, MD
United States, New York
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Contact: Andrew Shaw | 516-562-2591 | anshaw@northwell.edu
Principal Investigator: Meggan Mackay, MD
Sub-Investigator: Cynthia Aranow, MD
University of Rochester Medical Center
Rochester, New York, United States, 14642
Contact: Maria Allen | 585-275-7167 | Maria_Allen@urmc.Rochester.edu
Principal Investigator: Ummara Shah, MD
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Contact: Shruti Saxena-Beem | 919-966-0545 | shruti_saxena@med.unc.edu
Principal Investigator: Saira Z Sheikh, MD
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, OK 73104
Contact: Judy Goodman | 405-271-6670 ext. 34806 | judy-goodman@omrf.org
Principal Investigator: Christina Arriens, MD
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Contact: Stephanie Dezzutti | 843-792-8997 | brays@musc.edu
Principal Investigator: Gary S. Gilkeson, MD | 843-789-6799 | gilkeson@musc.edu
Sub-Investigator: Diane L. Kamen, MD, MSC
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.