Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions

Phase 1

Recruiting

• Conditions: Cardiovascular Disorders; Neurologic Disorders; Integumentary Disease; Autoimmune Diseases; Musculoskeletal Disorders; Sexual Dysfunction; Neurodegenerative Disorders; Pulmonary Disorders; Urologic Disorders; Diabetes Complications

• Registration Number: NCT04684602
• Lead Sponsor: Thomas Advanced Medical LLC

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.

Detailed Description

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.

This study investigates clinical outcomes of treatments for numerous indications including: Autoimmune, Cardiovascular, Diabetes, Integumentary, Neurologic / Neurodegenerative, Pulmonary, Orthopedic Diseases, Sexual Dysfunction, Urologic Disorders and Viral Illnesses.

Our hypotheses posit that regenerative treatments are both safe and statistically beneficial for a range of conditions. Outcomes will be determined by multiple valid outcome instruments that measure general quality of life information along with condition-specific information.

Study Timeline

• Study Start: 2020-07-09
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-29
• Primary Completion: 2030-07-09
• Study Completion: 2030-12-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Age 18 and older
• Ability to provide informed consent
• Availability for follow up visits

Exclusion Criteria

• Active or recent malignancy (within last 2 years)
• Pregnancy or breast-feeding
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months.	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.	Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.
Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.	Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.
Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months.	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.	Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best)
Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months.	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months 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.
Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.	Upper Extremity Outcome Instrument
Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months.	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.	Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.
Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.	COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.
Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months.	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.	Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.

Trial Locations

Locations (1)

Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites; 🇺🇸 Culver City, California, United States