NCT03899298|Not Yet RecruitingPhase 1DMC

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

Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions

R3 Stem Cell ClinicalTrials.gov

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1 other identifier

#2018/10/11

Study Type

interventional

Target

5,000

Locations

0 countries

Sites

N/A

Timeline

RegisteredApr 2019

StartedSep 2019

CompletionMar 2029

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

5,000

participants targeted

Target at P75+ for phase_1

Timeline

35mo left

Started Sep 2019

Longer than P75 for phase_1

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.6 years study duration

Study Progress70%

Sep 2019Mar 2029

First Submitted

Initial submission to the registry

March 27, 2019

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed

5 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2029

Expected

Last Updated

August 22, 2019

Status Verified

March 1, 2019

Enrollment Period

4.6 years

First QC Date

March 27, 2019

Last Update Submit

August 20, 2019

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 therapyumbilical stem cellsamniotic stem cellsstem cellsregenerative mediciner3 stem cellperinatal tissueplacenta stem cell

Outcome Measures

Primary Outcomes (9)

Disabilities of Arm, Shoulder, Hand Questionnaire (DASH)
Upper Extremity Outcome Instrument
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.
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.
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.
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.
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.
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.
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.
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).
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.

Study Arms (7)

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.