Who is conducting the clinical trial?
Restem is conducting the study.
What is the purpose of the clinical trial?
Restem is a Phase 1 study utilizing umbilical cord lining-derived stem cell product (ULSC). The purpose of the study is to:
How does the medicine work?
ULSC works by supporting muscle repair and restoring immune system balance.
Will some people be given a placebo instead of the medicine?
While this is a placebo-controlled study, all participants will receive two doses of ULSC and two doses of placebo in one of two sequences: ULSC first and placebo second, or placebo first and ULSC second.
Will I know whether I am receiving the medicine or the placebo?
No, this is a double-blinded study.
How will the medicine be given?
ULSC and the placebo will be given as an intravenous (IV) infusion. This means the medicine is given through a needle in a blood vein, usually in your arm.
How long is the clinical trial?
Participation in the trial is expected to last approximately 21 months. During the first 9 months, participants will receive two doses of study medication and two doses of placebo. This will be followed by an additional 12 months of follow-up assessments.
What are the criteria to be included in the clinical trial?
You must:
The study team will:
What criteria would exclude me from the clinical trial?
You will not be able to take part if you:
Do I need to have a genetic test to be included? If so, will this be provided?
Yes, you must have a genetic test confirming your diagnosis to be eligible for this study. Genetic testing can take many weeks to complete. Learn more about genetic testing.
How will the study team determine whether I can take part in the study?
The first step is usually a pre-screening discussion to talk through the study details, including the eligibility criteria. The study doctor or coordinator may have additional pre-screening steps for you to complete. If the team believes you may be a good fit, you will be scheduled for an in-person screening visit.
Your screening visit will take place at a study site. At this visit, you will learn more about the study and provide your consent to proceed. Then, the study team will perform all the tests needed to determine if you can take part in the study. This could take several hours, or you may need multiple visits. After all your test results come back, the study team will tell you whether you qualify for the study. This screening process can take up to 8 weeks.
What activities will I be asked to do?
How many study visits are there? Are they in-person or virtual?
You will be asked to attend 11 in-person visits and 5 virtual visits.
Will I have to stay overnight for any visits?
In-patient stays are not required; however, study visits can span several days.
Will the medicine be offered to patients once the clinical trial is over?
No.
Will I have to pay for any medical expenses? Will my insurance be billed for any costs?
All costs associated with the trial are paid for by Restem. Your insurance may be billed for standard of care costs that aren’t part of the study.
Will I be reimbursed for travel costs?
Travel may be reimbursed for eligible patients. Check with the study site for confirmation based on your needs.
Will I be paid a stipend for being in the clinical trial?
A stipend is paid to cover your time and effort in participating in this trial. The amount varies per visit.
Who is paying for the clinical trial?
Restem is paying for the study.
How many volunteers are needed?
The study needs 16 patients. However, many volunteers are needed because not everyone who volunteers will be able to participate.
Where are the study sites that are conducting the clinical trial?
The study is conducted at Stanford University in Palo Alto, California in the US. To find the specific site, visit clinicaltrials.gov and click on “Contacts and Locations” in the sidebar to open a list of locations. More locations may open as the study progresses.
How do I contact my study site to learn more and sign up?
To find specific sites, visit clinicaltrials.gov and click on “Contacts and Locations” in the sidebar to open a list of locations.
If your study site is marked as “Recruiting,” there should be an email and/or phone number listed for contact. Sometimes there is also contact information listed for sites that are “Not Yet Recruiting.” You should email and call these contacts and let them know that you are interested in the Restem study. If you are able and willing to travel to multiple different sites, you should contact each site individually.
What will happen after I contact my study site?
It can take several weeks to hear back, so be patient. Make sure you provide your email and phone number to make it easier for the coordinators to contact you. You should also keep checking in on a monthly basis – this helps the study team know that you are committed to completing the clinical trial.
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