Proposed Clinical Study Protocol for KidneyCell

Bioelectric Stimulation + Micro Infusion Pump Repeat Delivery of KC-15 Stem Cell & Growth Factor Based Composition for Patients with Moderate to Severe Chronic Kidney Disease

Proposed DRAFT

Clinical Study Protocol for KidneyCell – Bioelectric Stimulation + Micro Infusion Pump Repeat Delivery of KC-15 Stem Cell & Growth Factor Based Composition for Patients with Moderate to Severe Chronic Kidney Disease

Study Description

Background: More than 30,000,000 Americans have Chronic Kidney Disease. 661,000 Americans are currently in kidney failure. Close to 1 billion people worldwide or 13 to 18% of the total population has some form of chronic kidney disease. Kidney transplant patients often have to wait 10 years for a donor. Ant-rejection drugs for kidney transplant patients costs more than $85,000 annually. A kidney transplant itself costs > $200,000 including immediate followup needs. Chronic kidney dialysis patients cost the healthcare system over $100,000 annually. No therapy today is able to regenerate a person’s own kidney to avoid getting a transplant. The KidneyCell team has developed an implantable micro bioelectric stimulator designed to control release of 19+ regeneration promoting proteins including SDF-1 a known homing signal. Bioelectric stimulation protocols and sequences include those for managing inflammation and high blood pressure as well as pancreas revival all of which are underlying root causes of kidney failure. The KidneyCell therapy combines this bioelectrical stimulation with a micro infusion pump for repeated delivery of the KC-15 fifteen component kidney regeneration composition comprised of stem cells, growth factors, amniotic fluid, PRF, exosomes, micro RNAs, alkaloids, nutrient engineered hydrogel and kidney matrix.

Brief Summary:
To assess the safety of bioelectric stimulation and micro infusion pump repeat delivery of KC-15 mixed stem cell based composition with Moderate to Severe Chronic Kidney Disease
To assess the efficacy of bioelectric stimulation and micro infusion pump repeat delivery of KC-15 mixed stem cell based composition Moderate to Severe Chronic Kidney Disease

Condition or disease  Intervention/treatment  Phase 
Moderate to Severe Chronic Kidney Disease Device:  Bioelectric stimulator programmed to release up to 19 regeneration promoting proteins including SDF-1 a known stem cell homing signal and pacing infusion leads directed to kidneys. Biologic:  Fifteen component KC-15 kidney regeneration composition comprised of autologous stem cells, growth factors, PRF, amniotic fluid, exosomes, micro RNAs, selected alkaloids, nutrient engineered hydrogel and kidney matrix.  Phase 1Phase 2

Study Design

Study Type  : Interventional  (Clinical Trial)
Estimated  Enrollment  : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioelectric Kidney Regeneration
A Phase I/II Study to Evaluate the Safety and Efficacy of Bioelectric Stimulation plus micro infusion pump repeated delivery of KC-15 stem cell & growth factor based composition Moderate to Severe Chronic Kidney Disease
Anticipated  Study Start Date  : ****. , 2019
Estimated  Primary Completion Date  : December  2019
Estimated  Study Completion Date  : March 2020 

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

U.S. FDA Resources

Arms and Interventions

Arm  Intervention/treatment 
Experimental: Low dose:

Bioelectric stimulation 40 minutes 2X a week for 16 weeks
 Biologic : KC-15 Mixed Composition 

2mls weekly for 16 weeks 
Experimental: Middle dose

Bioelectric stimulation 2 hours a day for 16 weeks 
 Biologic:  KC-15 Mixed Composition 

2mls daily for 16 weeks 
Experimental: High dose

Bioelectric stimulation 24 hours a day constant for 48 weeks 
 Biologic:  KC-15 Mixed Composition 

2mls an hour 8 hours a day for 48 weeks

Outcome Measures

Primary Outcome Measures  :

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Week 48 after first and final treatment sessions  ]
    for Phase I
  2. Change from baseline to Week 24 and 48 visits in estimated glomerular filtration rate (eGFR) [ Time Frame: Week 0, 24 after first and last treatment sessions  ]
    or Phase II

Secondary Outcome Measures  (timing measures is in weeks after first AND last treatment sessions both) :

  1. Change from baseline to all post-treatment visits in creatinine [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  2. Change from baseline to all post-treatment visits in blood urea nitrogen (BUN) [ Time Frame: Weeks 2, 4, 12, 24, 36, 48 ]
  3. Change from baseline to all post-treatment visits in blood cystatin C [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  4. Change from baseline to all post-treatment visits in urine total protein-creatinine ratio (UPCR) [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  5. Change from baseline to all post-treatment visits in plasma neutrophil gelatinase-associated lipocalin (NGAL) by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  6. Change from baseline to all post-treatment visits in urine kidney injury molecule-1(KIM-1) [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  7. Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18) [ Time Frame: Weeks 2, 4, 12, 24, 36, 48 ]
  8. Change from baseline to all post-treatment visits in urine liver-type fatty acid-binding protein (L-FABP) [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  9. Change from baseline to all post-treatment visits in urine neutrophil gelatinase-associated lipocalin (NGAL) [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  10. Change from baseline to all post-treatment visits in urine cystatin C [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  11. Change from baseline to all post-treatment visits in hemoglobin A1c [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  12. Change from baseline to all post-treatment visits in fasting plasma glucose [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  13. Percentage of patients with hypoglycemia (defined as blood glucose < 55 mg/dL or 3.0 mmol/L) at all post-treatment visits [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  14. Change from baseline to all post-treatment visits in body weight [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  15. Change from baseline to all post-treatment visits in urine microalbumin-to-creatinine ratio (UMCR) [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  16. Change from baseline to all post-treatment visits in eGFR [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

 

Ages Eligible for Study: 20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
A patient is eligible for the study if all of the followings apply:
  1. Aged 20-80 years (inclusive)
  2. With chronic kidney disease (CKD)stage 3B to 4 (eGFR 15 to 44 mL/min/1.73m2 (inclusive)) Note : eGFR = estimated glomerular filtration rate
  3. Having provided informed consent
Exclusion Criteria:
Any patient meeting any of the exclusion criteria will be excluded from study participation.
  1. Ascertained hypersensitivity to any component used in the study Note: including gentamicin, DMSO, Agglutex (heperin)
  2. With inadequate hematologic function with: absolute neutrophil count (ANC) <1,500/μL OR platelets < 100,000/μL OR Hemoglobin < 8 g/dL
  3. With inadequate hepatic function with: serum bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (AKP) > 2.5 x the institutional upper limit of normal (ULN)
  4. With hemoglobin A1c (HbA1c) > 8.0%
  5. With serious prior or ongoing medical conditions (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that in the investigators’ opinion could interfere with the results of the trial or adversely affect the safety of the patient
  6. Pregnant or lactating women or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period
  7. With body mass index (BMI) greater or equal to 36 kg/m2
  8. With known history of human immunodeficiency virus (HIV) infection or any type of hepatitis
  9. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
  10. With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
  11. Having participated other investigational study within 4 weeks of entering this study
  12. Known or suspected abuse of alcohol or narcotics
  13. With known history of cancer within past 5 years
  14. With any autoimmune disease
  15. With cystic kidney disease or requiring kidney dialysis
  16. With precancerous condition or with cancer within past 5 years before Screening visit

Contacts and Locations

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): NCT02933827
Contacts
Contact:   Dr. Leslie Miller, Chief Medical Officer, KidneyCell les@leonhardtventures.com 
Locations
Sponsors and Collaborators
KidneyCell
Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc,
Leonhardt Ventures LLC
Investigators
TBD

More Information
Responsible Party: KidneyCell a Leonhardt Ventures Co. 
ClinicalTrials.gov Identifier: TBD
Other Study ID Numbers: TBD 
First Posted: April 8th, 2018
Last Update Posted:
Last Verified: April 8th, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

 

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