The BladderCell III study is examining for the first time the combination of bioelectrics and biologics for bladder function recovery.
Irvine, California and Porto Alegre, Brazil – Study is aimed to establish the initial pilot safety and efficacy of the BladderCell combination bioelectric stimulation and repeat delivery of biologics treatment of patients with stress incontinence.
The early feasibility pilot study is specifically examining the capability of the BladderCell technology to reduce urinary stress incontinence (UUI) episodes. Severity and frequency of urinary incontinence will be carefully assessed including number of urinations/day and number of pads used/day.
The study, which has an enrollment goal of 20 patients is a prospective, single arm, open label, combination therapy pilot trial. Bioelectric treatment will be 30 minutes twice a week for 8 weeks for a total of 16 bioelectric treatment sessions in clinic. Biologics deliveries will be made by industry standard bladder injection methods once a month for 3 months for a total of 3 biologics treatment sessions in clinic by a certified urologist with Institutional Review Board (IRB) approval and supervision.
Study Name: BladderCell III – Bioelectric Stimulation and Direct Injection of Biologics for Treatment of Bladder Incontinence
Study Sponsor: BladderCell, a subsidiary of Leonhardt Ventures, LLC and a portfolio company in the Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. innovation and startup launch accelerator
Principle Investigators: Cristiane Carboni, MSC, PhD, Director Pelvic Floor World Clinic https://www.linkedin.com/in/cristiane-carboni-b6416646/?originalSubdomain=br, Alexandre Fornari, MD, Urology Clinic – https://www.researchgate.net/profile/Alexandre_Fornari
Number of Study Sites: 1
Study Location: Pelvic Floor Dysfunction Clinic, Porte Alegre, Brazil and
Santa Casa de Porte Alegre Hospital
Study Design: Prospective, Single Arm, Open Label, Combination Therapy, Pilot Trial
Number of Subjects: 10-20 with rolling enrollment
Number of Treatment Arms: 1 with two components
Duration of Each Treatment: 30 minutes for each BES treatment and
30-45 minutes for each cystoscopy and delivery of Biologics
Frequency of Treatments: 2 x’s/week for two months for BES
Baseline, months 1 & 2 of study for Biologic Delivery
Number of Treatments: 16 for BES, 3 for Biologic delivery
Stimulator to be Used: CE Mark and FDA 510K approved Mettler model 740 Stimulator
Bioelectric Stimulation Signals: SDF-1; VEGF; PDGF; IGF; Klotho; COL17A1
Injected Regenerative Products: Proprietary composition
Primary End Point: Change in questionaires and self-assessment of severity and frequency of urinary incontinence including number of urinations/day and number of pads used/day.
Secondary End Point: Safety of direct injection of multiple biologics combined with multiple sites of BES, as well as painful urination, hematuria lasting more than 3 days, urgency, or local irritation as sites of BES
The present study aims to evaluate the feasibility and efficacy of combining BES at three different sites of nerve stimulation, plus direct injection of multiple biologics into the bladder wall, on the improving bladder function and LTUS and frequency of incontinence using questionaires, clinical patient assessment as study end points, and objective quantitation to assess the reduction in severity of stress incontinence. The estimated primary completion date of the study is Spring 2021.
The decision to launch the BladderCell II study was supported by the initial pilot study of BladderCell completed in 2019 with success – see summary here > https://leonhardtventures.com/bladdercell-completes-landmark-first-in-human-clinical-study/. ;
The BladderCell first-in-human early feasibility study was a 30 patient, randomized clinical trial of to evaluate the potential safety and efficacy of the BladderCell bioelectric treatment system in patients with urge incontinence.
• At 2 months, 60% percent of all BladderCell-treated subjects were therapy responders and maintained the benefits after 2 months follow up. There were no serious adverse device-related events or unanticipated device-related events. The pilot results show consistent decreases in symptoms, improvements in quality of life and patient satisfaction. BladderCell, based in Irvine, California is focused on the development of (1) non-invasive and (2) implantable bioelectric stimulation devices including added repeat deliveries of biologics for treating the most severe advanced cases.
BladderCell has series of three products in development that are intended to be applied to patients based on the severity of their bladder dysfunction:
1. BladderCell is a non-invasive bioelectric stimulation only system for mild to moderate bladder dysfunction.
2. BladderCell Plus Lite Biologics is bioelectric + PRF and regenerative fluid therapy for moderate to severe patients.
3. BladderCell Plus Full Biologics utilizes patented bioelectric stimulation via an implantable micro stimulator, our BC-15 multi-component composition and a re-fillable under skin implantable micro infusion pump intended for use in treating advanced very severe bladder dysfunction. The slow infusion micro pump is intended to re-filled daily with 2mls of the BC-15 bladder regeneration composition.
Note – Bioelectric stimulators in development intended to deliver our patented signals to the target organ include bench top, palm size portable and implantable micro stimulator models. The bench top stimulator was utilized in this pilot feasibility study.
The core BladderCell technology platform and IP is based on precise bioelectric signaling sequences for stem cell homing via controlled expression of SDF1 and PDGF, new blood vessel growth via a full suite of angiogenic signals, muscle and elasticity regeneration via klotho, COL17A1, tropoelastin, LIM muscle and follistatin and nerve regeneration via IGF1, LIM muscle and sonic hedgehog. For treating highly severe cases we intend to include an implantable and re-fillable micro infusion pump re-filled daily with our proprietary BC-15 multi-component bladder regeneration mixed composition that may be comprised of any or all of these components in combination – hypoxia treated and klotho expressing genetically modified MSC stem cells, adipose tissue derived stromal fraction, endothelial progenitor cells, immature myoblasts, selected proteins and growth factors, selected exosomes, bioelecrically pre-treated PRF, amniotic fluid, nutrient hydrogel, selected alkaloids, Wharton’s Jelly, micro RNA gel, DNA methyltransferase 1 (Dnmt1) elastomers and bladder matrix.
BladderCell has over a 100 related patent claims https://patents.justia.com/inventor/howard-j-leonhardt issued and pending covering its one-of-a-kind technology platform.
BladderCell research team members filed the first of our series of bioelectric urinary regulation patents in 2004 – https://patents.justia.com/patent/20050113879 and since then we have implemented numerous improvements with new patents issued August 13th, 2013 https://bladdercell.com/wp-content/uploads/2019/09/pat8509887_Schuler.pdf and May 12th, 2020 https://patents.justia.com/patent/10646644
The devices used in this study manufactured in Anaheim, California have FDA 510K https://www.accessdata.fda.gov/cdrh_docs/pdf11/K113017.pdf market clearance for improving blood circulation, pain relief and muscle related healing including improvement of muscle motion and inflammation management. The specific microcurrent signaling programming for these studies falls within the cleared parameters for this device. Based on only the results of this small pilot study we are NOT making any claims that safety of efficacy has been proven for bladder dysfunction recovery at this time. New larger scale studies are forthcoming.
BladderCell is collaborating with a number of researchers that have completed independent electrical stimulation bladder recovery studies to improve our knowledge of how best to implement improvements forward. The product pipeline is still considered to be in development stage. If including these independent studies there is data available on over 150 patients to date. The BladderCell III study is be conducted by Leonhardt’s Launchpads Brazil a subsidiary representative office in Brazil of Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. with local final production of product and clinical study coordination in Brazil with local personnel.
BladderCell LTP http://www.bladdercell.com is a Licensable Technology Platform with the Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. innovation and startup launch accelerator headquartered in Irvine, California with subsidiary branches in Petaluma/Santa Rosa, Utah, Brazil, Pittsburgh, The Netherlands, Minneapolis and Australia. The BladderCell core research team began stem cell based biologics and bioelectrics research for organ regeneration and healing in the late 1980’s. In 2000 the team began filing the first of a long series of patents for both bioelectric and biologics based organ regeneration and healing. In 2001 the team treated their first organ regeneration clinical patient with muscle stem cells derived from skeletal muscle. The first bladder and urinary regulation specific patent claims were filed in 2004 and over 100 related patent claims since have been filed with improvements to the original bladder regeneration and urinary regulation technology platform. The BladderCell and innovation accelerator business model is to seek out a strategic partner for commercialization after first in human studies have been completed and patents have been issued. B-Alive www.b-alivestim.com is a subsidiary of BladderCell founded by women and managed by women to apply, tailor, modify , customize, distribute and market BladderCell inventions and products to the unique needs of women.
About Leonhardt’s Launchpads:
Leonhardt’s Launchpads http://www.leonhardtventures.com is the organ regeneration focused innovation and startup launch accelerator arm of Leonhardt Ventures LLC based in Corona Del Mar, California. The Leonhardt team has been developing medtech and biotech inventions and products since the mid 1980s. The innovation accelerator has over 600 patents claims issued, pending, optioned or exclusively licensed covering bioelectric and biologics based organ regeneration and healing including over 100 patent claims related to bladder regeneration directly or indirectly – https://patents.justia.com/inventor/howard-j-leonhardt
Warning and Disclaimers: Product(s) are not yet proven safe or effective. Patents pending may not be issued. Patents licensed or optioned may not be maintained. Patents issued may be invalidated or may not be maintained. Products are in early stage development. Forward looking statements may change without notice. As an investment these startups mentioned are in the highest risk category for total loss and only suitable for sophisticated experienced accredited investors. The company does not have on hand sufficient resources to bring these products through clinical studies and certainly not enough resources to bring them fully to market, and may not obtain these resources. The company is underinsured compared to comparable companies on our sector. The company is under staffed and under funded compared to most other participants in this space. Due to a small staff at the accelerator to maintain all web sites and other published materials across over 30 innovation developments they may not be fully up to date and there may be out date inaccurate information. If you have any questions on our products or our company please write us to ask.
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Leonhardt’s Launchpads Utah, Inc.
Research Lab @ 2500 S State St. #D249, Salt Lake City, UT 84115
Company Name: BladderCell LTP a Leonhardt’s Launchpads startup
Full Name: Howard J. Leonhardt
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