Menu
Recruiting NCT04684602

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

Phase I / Phase II Interventional Autoimmune Diseases Cardiovascular Disorders Diabetes Complications Integumentary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PrimePro™/ PrimeMSK™.
Who it may be relevant to
Registry conditions: Autoimmune Diseases, Cardiovascular Disorders, Diabetes Complications, Integumentary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions

Overview

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.

Interventions

  • Biological PrimePro™/ PrimeMSK™
    Injection via condition specific route of administration.

Primary outcome measures

  • Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Southern California Hospital at Culver City / Southern California Hospital at Hollywood / — Culver City

Identifiers

NCT: NCT04684602 · ICSS-2020-032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗