Currently Enrolling
Interventional

FREEDOM-1

A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors

Brief Description

FREEDOM-1 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. FREEDOM-1 will evaluate the safety, effectiveness, and tolerability of FCR001 cell therapy in living donor kidney transplantation compared to the current standard treatment of immunosuppressive medicines. This study is now enrolling adult recipients who plan to undergo their first or second kidney transplant from a living donor.

Trial Physician / Study Coordinator

Denise Sumerlin

Email Phone 734-647-0351
Site Name

The University of Michigan Hospitals & Health System
1500 E Medical Center Dr, Ann Arbor, MI 48109

Sponsor

Talaris Therapeutics

Study Drug

FCR001

Estimated enrollment

120 donor and recipient pairs

Estimated end date

April 2025

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.
Currently Enrolling
Interventional

FREEDOM-1

A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors

Brief Description

FREEDOM-1 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. FREEDOM-1 will evaluate the safety, effectiveness, and tolerability of FCR001 cell therapy in living donor kidney transplantation compared to the current standard treatment of immunosuppressive medicines. This study is now enrolling adult recipients who plan to undergo their first or second kidney transplant from a living donor.

Trial is for people with

This trial is for people who plan to undergo a living donor kidney transplant.

Patients may qualify for the FREEDOM-1 Study if…
• They are at least 18 years old
• Their doctor has recommended that they should have a kidney transplant
• This would be their first or second kidney transplant
• They have a suitable living kidney donor between ages 18-60 has been identified
• The living kidney donor is willing to undergo standard mobilization and apheresis procedures to donate his/her stem cells
• They have not been diagnosed with or treated for any type of cancer

Study Goal

The goal of FREEDOM-1 is to determine if FCR001 has the potential to help prevent the rejection of the donor kidney and eliminate the need for lifelong immunosuppressive medicines.

What is involved for the Patient?

Study participants and their living donors who enroll in FREEDOM-1 will be randomly assigned as a pair to receive either FCR001 or the current standard treatment of immunosuppressive medicines. FCR001 recipients will receive FCR001 cell therapy and initial immunosuppressive medicines with the potential withdrawal of immunosuppressive medicines beginning 6 to 12 months post-transplant.

FCR001 Recipient:
• 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.
• 4 days prior to kidney transplant: 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 0: Kidney transplant surgery
• Day 1: FCR001 therapy is infused into the recipient.
• 0-6 months post-transplant: The patient remains on standard immunosuppression and returns to the clinic at regular intervals for routine monitoring.
• 6-9 months post-transplant: If after the first six months a recipient’s body has accepted the donor’s stem cells, a state known as “chimerism,” immunosuppressive medicines will be tapered and potentially discontinued after month 12. Kidney biopsies will be performed at months 6, 12, 24, 36, and 60.
• 5 years post-transplant: 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.
• Day 0: Kidney transplant surgery
• 1 year post-transplant: Follow-up period

Control Recipient:
• Day 0: Kidney transplant surgery
• Post-transplant: standard of care
• 5 year follow-up

Control Donor:
• No additional pre- or post-transplant activities required.
• Day 0: Kidney transplant surgery

Ann Arbor, MI
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.