FCR001 for Scleroderma
(FREEDOM-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called FCR001 for individuals with rapidly worsening Diffuse Cutaneous Systemic Sclerosis (dcSSc), a serious skin and organ condition. The goal is to determine if this stem cell therapy is safe and effective in improving symptoms. Those diagnosed with dcSSc for less than five years and who have tried immunosuppressive treatments might be suitable candidates, especially if they have lung or kidney issues related to the condition. Participants will receive a single infusion of FCR001, derived from specially prepared blood cells. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it mentions a washout period for scleroderma-specific therapies. You may need to discuss your current medications with the trial team to understand any specific requirements.
Is there any evidence suggesting that FCR001 cell therapy is likely to be safe for humans?
Research has shown that FCR001, a type of stem cell treatment, has been tested in studies involving kidney transplants. These studies explore whether it can help the body accept new organs without long-term anti-rejection drugs. However, some serious side effects have occurred. For instance, in one kidney transplant study, a patient died due to complications from graft-versus-host disease (GvHD), where donor cells attack the recipient's body.
While reducing the need for anti-rejection medication offers potential benefits, these risks are significant. Anyone considering joining a trial should carefully consider these risks and discuss them with a healthcare professional.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for rapidly progressive diffuse cutaneous systemic sclerosis, which typically involve immunosuppressive drugs like methotrexate or mycophenolate mofetil, FCR001 offers a unique approach as a stem cell therapy. It's derived from cryopreserved allogeneic stem cells, meaning it uses stem cells from a donor's mobilized peripheral blood, which are then infused into the patient. This method could potentially reset the immune system, offering a more targeted and possibly longer-lasting effect. Researchers are excited about FCR001 because it represents a new mechanism of action that might bring significant improvements in managing this challenging condition.
What evidence suggests that FCR001 cell therapy might be an effective treatment for rapidly progressive Diffuse Cutaneous Systemic Sclerosis?
Research has shown that FCR001 cell therapy, the treatment under study in this trial, is promising because it helps create a "dual immune system" in patients. This means part of the immune system comes from a donor, while the rest remains from the patient. In an earlier study, 72% of people who received FCR001 developed a stable mix of these immune cells, allowing them to stop taking all immune-suppressing drugs. This is important because many patients accepted donor cells without rejection. Although researchers have mainly studied this treatment for kidney transplants, it might also help treat conditions like diffuse cutaneous systemic sclerosis (dcSSc) by altering the immune system's response.35678
Who Is on the Research Team?
Joel Weinthal, MD
Principal Investigator
Talaris Therapeutics
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Nonmyeloablative Conditioning
Participants undergo nonmyeloablative conditioning prior to receiving FCR001 cell therapy
Treatment
Participants receive a single infusion of FCR001 cell therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FCR001
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood cells and delivered as a single infusion with a nonmyeloablative conditioning regimen.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Talaris Therapeutics Inc.
Lead Sponsor
Citations
Immune tolerance via FCR001 cell therapy compared with ...
Real-world evidence (RWE) methods were employed to compare the safety and efficacy of non-myeloablative conditioning with FCR001 with standard ...
2.
ashpublications.org
ashpublications.org/blood/article/140/Supplement%201/12675/489403/Hematopoietic-Stem-Cell-Transplantation-withHematopoietic Stem Cell Transplantation with FCR001 Can ...
Hematopoietic stem cell transplantation with FCR001 can induce durable red blood cell chimerism in a majority of recipients: results of a Phase II trial.
Immune tolerance via FCR001 cell therapy compared with ...
Among the FCR001 recipients, 26 (72%) developed persistent chimerism allowing durable elimination of all immunosuppression. There was no significant difference ...
FCR001 in Kidney Transplant
The goal of FCR001 treatment is to induce immune tolerance by creating a “dual immune system” (part donor and part recipient) in the transplant recipient. These ...
Talaris' Cell Therapy for Organ Rejection
The goal of the FREEDOM-1 trial is to assess the potential of FCR001 to induce durable immune tolerance to the transplanted kidney without the ...
NCT05098145 | A Safety and Efficacy Study of FCR001 in ...
This is a multicenter, open-label study to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly ...
7.
tts2022.org
tts2022.org/images/sponsor_logos/Talaris/TAL2112663A_1-pager_Overall_Clinical_Trial_Program_updated_21July2022.pdfTalaris Therapeutics FCR001 Clinical Program Overview
The goal of FCR001 treatment is to induce immune tolerance by creating a “dual immune system” (part donor and part recipient) in the transplant recipient.
GvHD Leads to Death in FCR001 Living Donor Kidney ...
A patient that received a living donor kidney transplant and was treated with FCR001 as part of the phase 3 FREEDOM-1 trial (NCT03995901) has died.
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