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Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions

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: NCT03899298
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
R3 Stem Cell

Tracking Information
First Submitted Date  ICMJE March 27, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date August 22, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date March 20, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Disabilities of Arm, Shoulder, Hand Questionnaire (DASH) [ Time Frame: Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. ]
    Upper Extremity Outcome Instrument
  • Sexual Health Inventory for Men Questionnaire (SHIM) [ Time Frame: Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. ]
    Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.
  • Kidney Disease and Quality of Life Questionnaire (KDQOL) [ Time Frame: Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. ]
    Renal Function Outcome Instrument. Raw, precoded numeric values for 36 items are transformed linearly to a 0 to 100 range, with higher scores reflecting better quality of life.
  • Assessment of Quality of Life Questionnaire (AQOL) [ Time Frame: Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. ]
    General Health Outcome Instrument. Each instrument is used to derive a simple psychometric score for health related quality of life (HRQoL) and to provide profile scores on the different dimensions or items of the descriptive systems. The score is derived by adding the unweighted response order of each question, with a lower score denoting a better quality of life.
  • Clinical Chronic Obstructive Pulmonary Disease Questionnaire [ Time Frame: Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. ]
    COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.
  • Mini Mental State Examination (MMSE) [ Time Frame: Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. ]
    Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.
  • O'Leary/Sant Questionnaire [ Time Frame: Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. ]
    Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.
  • Oswestry Low Back Pain Disability Questionnaire [ Time Frame: Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. ]
    Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.
  • Western Ontario and McMaster Osteoarthritis Index (WOMAC) [ Time Frame: Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. ]
    Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
Official Title  ICMJE Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions
Brief Summary To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.
Detailed Description

The study will be ongoing for patient inclusion and data acquisition. Patients who have Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions will be included.

The study has been approved by an Alion accredited Institutional Review Board, Solutions IRB, as of March 2019.

Depending on the condition, patients may receive a series of therapies via one or more of the following methods: intravenous, injection, intra-nasal and/or nebulizer. R3 has several "best practice" therapy protocols that participating practices will follow. Should a patient have conditions that fall into more than one condition category, he or she can still be included with the protocols being received for each condition(s).

Here is a specific administration for each condition category:

  1. Orthopedic Condition = Injection
  2. Neurologic Disease = IV Infusion and Intranasal Procedure. The exception is with Peripheral Neuropathy, where participants receive a series of injections along with an IV Infusion Procedure.
  3. Urologic = Injection
  4. Autoimmune = IV Infusion
  5. Cardiac = IV Infusion
  6. Pulmonary = IV Infusion plus Nebulizer
  7. Renal = IV Infusion

Pre, Intra and Post procedure data acquisition will occur at various time frames up to 10 years. Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months and then on average each year, up to 10 years. Patients will pay for procedures, and no randomization will occur.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The study will be ongoing for patient inclusion and data acquisition. Patients will be separated into one of seven categories including: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The treatments will not be randomized or blinded. This is a partially patient funded study. The study has been approved by an Alion accredited Institutional Review Board, Solutions IRB as of March 2019.
Masking: None (Open Label)
Masking Description:
No masking.
Primary Purpose: Treatment
Condition  ICMJE
  • Orthopedic Disorder
  • Neurologic Disorder
  • Urologic Diseases
  • Erectile Dysfunction
  • Autoimmune Diseases
  • Renal Failure
  • Renal Insufficiency
  • Kidney Diseases
  • Cardiac Event
  • Cardiomyopathies
  • CHF
  • Pulmonary Disease
  • COPD
  • Alzheimer Disease
  • Stroke
  • Neuropathy;Peripheral
  • Arthritis
Intervention  ICMJE Biological: Amniotic and Umbilical Cord Tissue Procedure
Amniotic and Umbilical Cord Cell Therapy with protocols dependent on the patient condition. Protocols include options for IV, Injection, Intranasal and/or Nebulizer.
Other Names:
  • Amniotic and Umbilical Cord Tissue Infusion
  • Amniotic and Umbilical Cord Tissue Nebulizer
  • Amniotic and Umbilical Cord Tissue Injection
  • Amniotic and Umbilical Cord Tissue Intranasal
Study Arms  ICMJE
  • Experimental: Amniotic and Umbilical Cord Tissue for Autoimmune Conditions
    Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for autoimmune conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.
    Intervention: Biological: Amniotic and Umbilical Cord Tissue Procedure
  • Experimental: Amniotic and Umbilical Cord Tissue for Orthopedic Conditions
    Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for orthopedic conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.
    Intervention: Biological: Amniotic and Umbilical Cord Tissue Procedure
  • Experimental: Amniotic and Umbilical Cord Tissue for Neurologic Conditions
    Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for neurologic conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.
    Intervention: Biological: Amniotic and Umbilical Cord Tissue Procedure
  • Experimental: Amniotic and Umbilical Cord Tissue for Urologic Conditions
    Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for urologic conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.
    Intervention: Biological: Amniotic and Umbilical Cord Tissue Procedure
  • Experimental: Amniotic and Umbilical Cord Tissue for Cardiac Conditions
    Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for cardiac conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.
    Intervention: Biological: Amniotic and Umbilical Cord Tissue Procedure
  • Experimental: Amniotic and Umbilical Cord Tissue for Renal Conditions
    Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for renal conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.
    Intervention: Biological: Amniotic and Umbilical Cord Tissue Procedure
  • Experimental: Amniotic and Umbilical Cord Tissue for Pulmonary Conditions
    Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for pulmonary conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.
    Intervention: Biological: Amniotic and Umbilical Cord Tissue Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2019)
5000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 20, 2029
Estimated Primary Completion Date March 20, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18 and over.
  2. Ability to attend follow up visits or at least converse on phone or complete email follow up forms.
  3. Competent to understand the study protocol and provide voluntary informed consent.
  4. Patients with any of the following conditions: Arthritis (Degenerative, Rheumatoid, Psoriatic, Lupus, Gout), Sports or Overuse Injuries (e.g. Rotator Cuff injury, Tennis Elbow), Chronic Kidney Disease (may be on dialysis), Back/Neck Pain, Erectile Dysfunction, Peyronie's Disease, Alzheimer's Disease, Parkinson's Disease, Neuropathy, Post-Stroke, Post-Concussion Syndrome, COPD, Emphysema, Pulmonary Fibrosis, Post myocardial infarction (at least 6 months out), Cardiomyopathy, Congestive Heart Failure.

Exclusion Criteria:

  1. Active Cancer
  2. Pregnancy, Lactating
  3. Severe Clotting disorder
  4. Myocardial Infarction less than six months ago.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: David L Greene, MD, MBA (844) 438-7836 info@r3stemcell.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT03899298
Other Study ID Numbers  ICMJE #2018/10/11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.
Responsible Party R3 Stem Cell
Study Sponsor  ICMJE R3 Stem Cell
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Greene, MD, MBA R3 Stem Cell
PRS Account R3 Stem Cell
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP