Clinical trial NCT03899298: Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
Official title: Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: 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
Keywords: stem cell therapy
umbilical stem cells
amniotic stem cells
stem cells
regenerative medicine
r3 stem cell
perinatal tissue
placenta stem cell
Lead sponsor: R3 Stem Cell
Sponsor class: INDUSTRY
First posted: 2019-04-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disabilities of Arm, Shoulder, Hand Questionnaire (DASH)
timeFrame: 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.
measure: Sexual Health Inventory for Men Questionnaire (SHIM)
timeFrame: 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.
measure: Kidney Disease and Quality of Life Questionnaire (KDQOL)
timeFrame: 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.
measure: Assessment of Quality of Life Questionnaire (AQOL)
timeFrame: 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.
measure: Clinical Chronic Obstructive Pulmonary Disease Questionnaire
timeFrame: 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.
measure: Mini Mental State Examination (MMSE)
timeFrame: 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.
measure: O'Leary/Sant Questionnaire
timeFrame: 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.
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 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.
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: R3 Stem Cell
name: David Greene, MD, MBA
role: STUDY_DIRECTOR
References: