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A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115345
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : June 19, 2020
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
inRegen

Brief Summary:
A PHASE 1, OPEN-LABEL SAFETY, TOLERABILITY, AND EARLY EFFICACY STUDY OF A RENAL AUTOLOGOUS CELL THERAPY (REACT) IN PATIENTS WITH CHRONIC KIDNEY DISEASE FROM CONGENITAL ANOMALIES OF THE KIDNEY AND URINARY TRACT (CAKUT) (REGEN-004)

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Congenital Anomalies of Kidney and Urinary Tract Biological: REACT - renal autologous cell therapy Phase 1

Detailed Description:

A Renal Autologous Cell Therapy (REACT) is an injectable product composed of selected renal cells (SRC) formulated in a biomaterial (gelatin-based hydrogel). Renal cells obtained from autologous kidney biopsy tissue will be expanded and SRC selected. Selected renal cells (SRC) will be formulated in a gelatin-based hydrogel at a concentration of 100 x 106 cells/mL to improve stability during transport and delivery upon injection into the renal cortex. Porcine gelatin will be dissolved in buffer to form the thermally responsive hydrogel. Although fluid at room temperature, this biomaterial gels when cooled to refrigerated temperature (2 to 8ºC). Prior to injection, the REACT investigational product must be warmed to ≥20° up to 26°C to liquefy the hydrogel. This sterile cell preparation (REACT) will be contained in a sterile 10 mL syringe and shipped to the clinical site for use.

The dose of Renal Autologous Cell Therapy (REACT) for subjects in the Phase 1 clinical trials (TNG-CL010 and TNG-CL011) was 3 x 106 SRC /g estimated kidney weight. Similarly, in the present study, each REACT injection will contain 3 x 106 cells/g. Since the concentration of selected renal cells (SRC) is 100 x 106 cells/mL of REACT, the dosing volume will be 3.0 mL for each 100 g of kidney weight. The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula (Length x width AP plane x width Transverse plan x .62).

It is anticipated that all subjects will receive two planned Renal Autologous Cell Therapy (REACT) injections to allow dose-finding and evaluate the duration of effects. The scientific rationale, based on non-clinical studies, is that the biologically active component of REACT (homologous, autologous, SRC) delays progression of experimental models of Chronic Kidney Disease (CKD) by augmenting renal structure and function. As a result, the more cells that can be infused, the greater the potential improvement in renal function.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-Label Safety, Tolerability, and Early Efficacy Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: REACT -renal autologous cell therapy
The dose of Renal Autologous Cell Therapy (REACT) for subjects in the Phase 1 clinical trials (TNG-CL010 and TNG-CL011) was 3 x 106 SRC /g estimated kidney weight. Similarly, in the present study, each REACT injection will contain 3 x 106 cells/g. Since the concentration of selected renal cells (SRC) is 100 x 106 cells/mL of REACT, the dosing volume will be 3.0 mL for each 100 g of kidney weight. The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula (Length x width AP plane x width Transverse plan x .62).
Biological: REACT - renal autologous cell therapy
Renal Autologous Cell Therapy (REACT) is made from expanded autologous selected renal cells obtained from each individual subject's kidney biopsy. To manufacture REACT, biopsy tissue from each enrolled subject will be sent to Twin City Bio LLC, in whose facilities renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin-based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site.




Primary Outcome Measures :
  1. Assess change in eGFR and observe incidence of renal-specific procedure and/or product related adverse events (AEs) through 24 months following two Renal Autologous Cell Therapy (REACT) injections [Safety]. [ Time Frame: 24 months following last REACT injection ]
    The primary objective is to assess the safety and optimal delivery of Renal Autologous Cell Therapy (REACT) injected at one site in a recipient kidney as measured by procedure- and/or product related adverse events (AEs) through 24 months post-treatment.


Secondary Outcome Measures :
  1. Number of subjects with renal-specific adverse events over a 24-month period following injection of Renal Autologous Cell Therapy (REACT). [ Time Frame: 24 months following last REACT injection ]
    The number of subjects with renal-specific adverse events over a 24-month period following injection of Renal Autologous Cell Therapy (REACT) will be observed utilizing renal-specific laboratory assessments.The secondary objective will compare the results of laboratory tests from baseline through 12 months following REACT injection, followed by an additional observational period of 18 months for a total of 24 months of observation. Each subject's baseline rate of CKD disease progression serves as his/her own "control" to monitor for changes in renal insufficiency over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is male or female, 18 to 65 years of age on the date of informed consent.
  2. The patient has a documented history of a corrected abnormality of the kidney and/or urinary tract (CAKUT) leading to renal dysfunction.
  3. The patient has an established diagnosis of Stage III/IV CKD not requiring renal dialysis, defined as having an eGFR between 14 and 50 mL/min/1.73 m2 inclusive at the time of screening.
  4. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). At the time of the biopsy and injections, the subject's BP should not be significantly below the previously recorded stable pressure.
  5. A minimum of three measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit and within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.
  6. The patient is willing and able to refrain from NSAID consumption (including aspirin) as well as clopidogrel, prasugrel, or other platelet inhibitors during the period beginning 7 days before through 7 days after both the renal biopsy and REACT injection(s).
  7. The patient is willing and able to refrain from consumption of fish oil and platelet aggregation inhibitors, such as dipyridamole (i.e., Persantine®), during the period beginning 7 days before through 7 days after both the renal biopsy and REACT injection(s).
  8. The patient is willing and able to cooperate with all aspects of the protocol.
  9. The patient is willing and able to provide signed informed consent.

Exclusion Criteria:

  1. The patient has a history of renal transplantation.
  2. The patient has a diagnosis of hydronephrosis, SFU Grade 4 or 5.
  3. The patient has an uncorrected VUR Grade 5.
  4. The patient has a diffuse cortical thickness throughout the kidney measuring < 5 mm on MRI that prevents safe cortical biopsy.

    a. Note: CAKUT parenchymal changes in the kidney are asymmetric and areas of cortical sparing amendable to biopsy may be present.

  5. The patient has a known allergy or contraindication(s) or has experienced severe systemic reaction(s) to kanamycin or structurally similar aminoglycoside antibiotic(s).
  6. The patient has a history of anaphylactic or severe systemic reaction(s) or contraindication(s) to human blood products or materials of animal origin (e.g., bovine, porcine).
  7. The patient has a history of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives.
  8. The patient has a clinically significant infection requiring parenteral antibiotics within 6 weeks of REACT injection.
  9. The patient has acute kidney injury or has experienced a rapid decline in renal function during the last 3 months prior to REACT injection.
  10. The patient has any of the following conditions prior to REACT injection: renal tumors, polycystic kidney disease, anatomic abnormalities that would interfere with the REACT injection procedure or evidence of a urinary tract infection.

    a. Note: anatomic abnormalities are not exclusionary if kidney remains accessible and meets the criteria to receive REACT injection.

  11. The patient has class III or IV heart failure (NYHA Functional Classification).
  12. The patient has FEV1/FVC ≤ [less than or equal to] 70%, and/or significant restrictive lung disease.
  13. The patient has a history of cancer within the past 3 years (excluding non-melanoma skin cancer and carcinoma in situ of the cervix).
  14. The patient has clinically significant hepatic disease (ALT or AST greater than 3 times the upper limit of normal) as assessed at the Screening Visit.
  15. The patient is positive for active infection with Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), and/or Human Immunodeficiency Virus (HIV) as assessed at the Screening Visit.
  16. The patient has a history of active tuberculosis (TB) requiring treatment within the past 3 years.
  17. The patient is immunocompromised or is receiving immunosuppressive agents, including individuals treated for chronic glomerulonephritis within 3 months of REACT injection.

    a. Note: inhaled corticosteroids and chronic low-dose corticosteroids (less than or equal to 7.5 mg per day) are permitted as are brief pulsed corticosteroids for intermittent symptoms (e.g., asthma).

  18. The patient has a life expectancy less than 2 years.
  19. The female patient is pregnant, lactating (breast feeding), or planning a pregnancy during the course of the study. Or, the female patient is of child-bearing potential and is not using a highly effective method(s) of birth control, including sexual abstinence. Or, the female patient is unwilling to continue using a highly-effective method of birth control throughout the duration of the study.]
  20. The patient has a history of active alcohol and/or drug abuse that, in the judgment of the Investigator, would impair the patient's ability to comply with the protocol.
  21. The patient's health status would, in the judgment of the Investigator, be jeopardized by participating in the study.
  22. The patient has used an investigational product within 3 months prior to REACT injection without receiving written consent from the Medical Monitor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115345


Contacts
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Contact: Karla Kennedy 5136195545 kkennedy@ctifacts.com

Locations
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United States, Idaho
Boise Kidney & Hypertension Institute Recruiting
Boise, Idaho, United States, 83642
Contact: Amy Henderson       Amy.Henderson@frenovarenalresearch.com   
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Sharon Trevino    773-702-6201    strevino@bsd.uchicago.edu   
Principal Investigator: Benjamin Ko, MD         
United States, Louisiana
Renal Associates of Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Kayla Callahan       Kayla.Callahan@frenovarenalresearch.com   
United States, Michigan
Paragon Health Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Brianna Atkinson       Brianna.Atkinson@FrenovaRenalResearch.com   
United States, New York
Mt. Sinai Hospital Recruiting
New York, New York, United States, 45246
Contact: Ciara Guzman       ciara.guzman@mssm.edu   
Sponsors and Collaborators
inRegen
CTI Clinical Trial and Consulting Services
Investigators
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Study Director: Ashley Johns inRegen
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Responsible Party: inRegen
ClinicalTrials.gov Identifier: NCT04115345    
Other Study ID Numbers: REGEN-004
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Congenital Abnormalities
Urologic Diseases
Renal Insufficiency