Brief Summary

This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.

Trial Health

On Track

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

56mo left

Started Jul 2020

Longer than P75 for phase_1

Geographic Reach

1 country

1 active site

Status

recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

10.4 years study duration

Study Progress56%

Jul 2020Dec 2030

Study Start

First participant enrolled

July 9, 2020

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed

22 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed

9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2030

Expected

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2030

Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

10 years

First QC Date

December 2, 2020

Last Update Submit

April 27, 2022

Conditions

Autoimmune Diseases Cardiovascular Disorders Diabetes Complications Integumentary Disease Musculoskeletal Disorders Neurodegenerative Disorders Neurologic Disorders Pulmonary Disorders Sexual Dysfunction Urologic Disorders Viral Illness

Keywords

stem cell therapyumbilical cord stem cellsamniotic stem cellsstem cellsMSCMesenchymal Stem CellMedicinal Signaling CellErectile DysfunctionHeart DiseasesMental DisordersNeurocognitive DisordersNeurodegenerative DiseasesCentral Nervous System DiseasesTauopathiesBrain DiseasesDementiaDiseaseCardiomyopathiesUrologic DiseasesPeripheral Nervous System DiseasesNervous System DiseasesAlzheimer DiseaseMusculoskeletal DiseasesCardiovascular DiseasesImmune System DiseasesNeuromuscular DiseasesCovid-19

Outcome Measures

Primary Outcomes (8)

Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months.
General Health Outcome Instrument used to derive a simple psychometric score for health related quality of life which provides scores on various dimensions or items describing the 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 6 months and 12 months.
Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.
Upper Extremity Outcome Instrument
Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months.
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 6 months and 12 months.
Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.
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 6 months and 12 months.
Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months.
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 6 months and 12 months.
Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months.
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 6 months and 12 months.
Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.
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 6 months and 12 months.
Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months.
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 6 months and 12 months.

Study Arms (10)

Arm 1: Autoimmune Diseases

EXPERIMENTAL

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for autoimmune conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.