Orthopedic DisorderPhase 1NCT03899298
Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
A Phase 1 study testing Amniotic and Umbilical Cord Tissue Procedure in people with Orthopedic Disorder and Neurologic Disorder, run by R3 Stem Cell.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder, Neurologic Disorder, Urologic Diseases
- What is being tested?
- Amniotic and Umbilical Cord Tissue Procedure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 20 Mar 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and over.
- Ability to attend follow up visits or at least converse on phone or complete email follow up forms.
- Competent to understand the study protocol and provide voluntary informed consent.
- 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.
Who cannot join
- Active Cancer
- Pregnancy, Lactating
- Severe Clotting disorder
- Myocardial Infarction less than six months ago.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions
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.
Read the 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:
- Orthopedic Condition = Injection
- 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.
- Urologic = Injection
- Autoimmune = IV Infusion
- Cardiac = IV Infusion
- Pulmonary = IV Infusion plus Nebulizer
- 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.
- Conditions
- Orthopedic Disorder, Neurologic Disorder, Urologic Diseases, Erectile Dysfunction, Autoimmune Diseases, Renal Failure
- Being tested
- Amniotic and Umbilical Cord Tissue Procedure
- Keywords
- stem cell therapy, umbilical stem cells, amniotic stem cells, stem cells, regenerative medicine, r3 stem cell, perinatal tissue, placenta stem cell
- Medical subject headings
- Musculoskeletal Diseases, Nervous System Diseases, Urologic Diseases, Erectile Dysfunction, Autoimmune Diseases, Renal Insufficiency, Kidney Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic and Umbilical Cord Tissue ProcedureBiological
Also called Amniotic and Umbilical Cord Tissue Infusion, Amniotic and Umbilical Cord Tissue Nebulizer, Amniotic and Umbilical Cord Tissue Injection, Amniotic and Umbilical Cord Tissue Intranasal
Amniotic and Umbilical Cord Cell Therapy with protocols dependent on the patient condition. Protocols include options for IV, Injection, Intranasal and/or Nebulizer.
| Study group | Role | What they receive |
|---|---|---|
| Amniotic and Umbilical Cord Tissue for Autoimmune Conditions | Experimental | 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. Receives: Biological: Amniotic and Umbilical Cord Tissue Procedure |
| Amniotic and Umbilical Cord Tissue for Orthopedic Conditions | Experimental | 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. Receives: Biological: Amniotic and Umbilical Cord Tissue Procedure |
| Amniotic and Umbilical Cord Tissue for Neurologic Conditions | Experimental | 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. Receives: Biological: Amniotic and Umbilical Cord Tissue Procedure |
| Amniotic and Umbilical Cord Tissue for Urologic Conditions | Experimental | 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. Receives: Biological: Amniotic and Umbilical Cord Tissue Procedure |
| Amniotic and Umbilical Cord Tissue for Cardiac Conditions | Experimental | 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. Receives: Biological: Amniotic and Umbilical Cord Tissue Procedure |
| Amniotic and Umbilical Cord Tissue for Renal Conditions | Experimental | 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. Receives: Biological: Amniotic and Umbilical Cord Tissue Procedure |
| Amniotic and Umbilical Cord Tissue for Pulmonary Conditions | Experimental | 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. Receives: Biological: Amniotic and Umbilical Cord Tissue Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of Arm, Shoulder, Hand Questionnaire (DASH)
Upper Extremity Outcome Instrument
Measured: 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.
Sexual Health Inventory for Men Questionnaire (SHIM)
Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.
Measured: 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.
Kidney Disease and Quality of Life Questionnaire (KDQOL)
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.
Measured: 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.
Assessment of Quality of Life Questionnaire (AQOL)
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.
Measured: 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.
Clinical Chronic Obstructive Pulmonary Disease Questionnaire
COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.
Measured: 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.
Mini Mental State Examination (MMSE)
Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.
Measured: 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.
O'Leary/Sant Questionnaire
Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.
Measured: 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.
Oswestry Low Back Pain Disability Questionnaire
Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.
Measured: 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.
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Sep 2019 (estimated)
- Primary completion20 Mar 2024 (estimated)
- Study completion20 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R3 Stem Cell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Greene, MD, MBA, Study director, R3 Stem Cell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899298
- Sponsor's protocol ID
- #2018/10/11
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.