Currently Enrolling
Interventional

FREEDOM-2

A Single-arm, Multi-center, Exploratory Safety and Efficacy Study of FCR001 Cell-based Therapy to Induce Donor-specific Tolerance in Previously Transplanted Recipients of a Kidney From a Living Donor, and Safety in FCR001 Donors

Brief Description

FREEDOM-2 is a clinical research study of an investigational cell therapy, called FCR001. FCR001 is comprised of living stem cells and other cells obtained from the kidney donor’s blood and administered as a one-time infusion into the recipient. The FREEDOM-2 study will assess the safety, tolerability, and initial effectiveness, of FCR001 cell therapy in recipients, 3-12 months after kidney transplantation from a living donor.

Trial Physician / Study Coordinator

Alyssa Dahmen, BSN-RN, CRNI

Email Phone 312-694-9084
Site Name

Northwestern Memorial Hospital
251 E Huron St, Chicago, IL 60611

Sponsor

Talaris Therapeutics

Study Drug

FCR001

Estimated enrollment

15 participants

Estimated end date

February 2029

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Find other locations for this trial:
Currently Enrolling
Interventional

FREEDOM-2

A Single-arm, Multi-center, Exploratory Safety and Efficacy Study of FCR001 Cell-based Therapy to Induce Donor-specific Tolerance in Previously Transplanted Recipients of a Kidney From a Living Donor, and Safety in FCR001 Donors

Brief Description

FREEDOM-2 is a clinical research study of an investigational cell therapy, called FCR001. FCR001 is comprised of living stem cells and other cells obtained from the kidney donor’s blood and administered as a one-time infusion into the recipient. The FREEDOM-2 study will assess the safety, tolerability, and initial effectiveness, of FCR001 cell therapy in recipients, 3-12 months after kidney transplantation from a living donor.

Trial is for people with

This trial is for people who have had a kidney transplant from a living donor in the last 3-12 months.

Patients may qualify for the FREEDOM-2 Study if…
• They are at least 18 years old
• They have received a kidney transplant from a living kidney donor 3 to 12 months before the screening visit
• They have not been diagnosed with any type of cancer
• Their donor is willing to undergo mobilization, apheresis, and 12-month safety follow-up
• They have not experienced any episodes of rejection
• They have adequate and stable kidney function

Study Goal

The goal of FREEDOM-2 is to determine if investigational cell therapy FCR001 following a patient’s kidney transplant, could prevent the rejection of the donor kidney and eliminate the need for life-long immunosuppression medicines.

What is involved for the Patient?

FCR001 Recipient:
• 3+ weeks prior to FCR001 Infusion: Collection of stem cells. This involves taking “mobilization” drugs for 5 days that stimulate stem cells to enter the blood from the bone marrow followed by collection of the stem cells by a routine blood filtering procedure called apheresis.
• 5 days prior to FCR001 Infusion: Conditioning with several drugs and low dose radiation. The conditioning allows acceptance of their donor’s stem cells contained in the FCR001 cell therapy.
• Day 1: FCR001 therapy is infused into the recipient.
• 0-12 months post FCR001 Infusion: The patient remains on standard immunosuppression and returns to the clinic at regular intervals for routine monitoring. Kidney biopsies will be performed at Months 6, 12, and 24.
• 1-year post FCR001 Infusion: Simple blood test to confirm that donor and recipient immune cells are coexisting in the recipient’s bone marrow. If so, the physician gradually lowers immunosuppression.
• 3 years post FCR001 Infusion: Follow-up period
FCR001 Donor:
• 3-8 weeks prior to kidney transplant: Collection of stem cells. This involves taking “mobilization” drugs for 5 days that stimulate stem cells to enter the blood from the bone marrow followed by collection of the stem cells by a routine blood filtering procedure called apheresis.
• One-year post-transplant: Follow-up period

Find other locations for this trial:
Chicago, IL
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

See other frequently asked questions
Did you know that some forms of kidney disease can be genetic?Researchers are continually discovering genetic causes of Nephrotic Syndrome.

Learn more about genetic causes of kidney disease and find out if you may be affected.