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Cell Therapy

FCR001 for Systemic Sclerosis (FREEDOM-3 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Talaris Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from infusion to 60 months
Awards & highlights

FREEDOM-3 Trial Summary

This trial will test a new cell therapy for people with a rapidly progressive form of scleroderma that is at risk for organ failure.

Eligible Conditions
  • Systemic Sclerosis

FREEDOM-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from infusion to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from infusion to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of recipient adverse events (AEs)
Incidence of recipient serious adverse events (SAEs)
Occurrence of Graft versus Host Disease (GvHD)
+2 more
Secondary outcome measures
Incidence of donor AEs
Incidence of donor SAEs
Percent donor whole blood chimerism
+1 more

FREEDOM-3 Trial Design

1Treatment groups
Experimental Treatment
Group I: FCR001Experimental Treatment1 Intervention
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 Location

Who is running the clinical trial?

Talaris Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
102 Total Patients Enrolled
Ken Abrams, MDStudy DirectorTalaris Therapeutics
2 Previous Clinical Trials
37 Total Patients Enrolled
Joel Weinthal, MDStudy DirectorTalaris Therapeutics

Media Library

FCR001 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05098145 — Phase 1 & 2
Systemic Sclerosis Research Study Groups: FCR001
Systemic Sclerosis Clinical Trial 2023: FCR001 Highlights & Side Effects. Trial Name: NCT05098145 — Phase 1 & 2
FCR001 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05098145 — Phase 1 & 2
Systemic Sclerosis Patient Testimony for trial: Trial Name: NCT05098145 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patients would best be suited for this clinical trial?

"The ideal candidate for this clinical trial would be between 18 and 70 years of age, suffering from diffuse scleroderma. Right now, the team is looking to enroll around 18 patients."

Answered by AI

Could you please tell me how many people are participating in this trial?

"The research indicates that this clinical trial is recruiting patients. The original posting date was on November 24th, 2021 and the latest update was March 4th, 2022. They are looking for a total of 18 participants from 1 site."

Answered by AI

Can elderly patients participate in this research?

"The specified age range for this trial is 18 to 70. However, there are 46 other trials that cater to minors and 388 that focus on patients above the age of retirement."

Answered by AI

Are people currently being signed up to participate in this clinical trial?

"Yes, the trial is recruiting patients at this time. According to the postings on clinicaltrials.gov, the study was first advertised on November 24th 2021 and updated as recently as March 4th of this year. They are looking for a total of 18 individuals across 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Non steroid anti inflammation drugs.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis
2021. "A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05098145.
~0 spots leftby Nov 2026
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