Actively Recruiting
Study of Stem Cell Therapy Using PrimePro17PrimeMSK17 for Treating Various Chronic and Acute Conditions Including Autoimmune, Cardiovascular, Diabetes, Neurologic, Pulmonary, Musculoskeletal, Sexual Dysfunction, Urologic, and Viral Illnesses
Led by Thomas Advanced Medical LLC · Updated on 2022-04-29
5000
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
T
Thomas Advanced Medical LLC
Lead Sponsor
H
HeartStem Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of stem cell therapy for treating a variety of acute and chronic conditions. This multi-site, multi-arm study focuses on regenerative treatments using amniotic and umbilical cord stem cell rich tissue. The study covers conditions including autoimmune diseases, cardiovascular disorders, diabetes complications, integumentary diseases, musculoskeletal disorders, neurological and neurodegenerative disorders, pulmonary disorders, sexual dysfunction, urologic disorders, and viral illnesses. The goal is to measure improvements based on validated quality of life and condition-specific tools. Participants will receive injections of PrimePro or PrimeMSK stem cell products administered through condition-specific routes. Each study arm targets a particular group of conditions to compare outcomes against established research. The treatments are given once with follow-up visits planned to assess changes over time. No placebo or control group is used, and the study is non-randomized with open-label participation. During the study, participants will undergo various assessments such as the 36-Item Short Form Survey SF-36 for quality of life, condition-specific questionnaires like the DASH for arm and shoulder disabilities, IIEF-5 for erectile function, clinical COPD questionnaire, MMSE for mental state, OLearySant questionnaire for interstitial cystitis, Oswestry Low Back Pain Disability Questionnaire, and WOMAC for osteoarthritis. Follow-up evaluations occur at 6 and 12 months after treatment to monitor progress. The study includes safety monitoring and requires participants to be available for follow-up visits over this time frame.
CONDITIONS
Brief Title
Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and older
- Ability to provide informed consent
- Availability for follow up visits
You will not qualify if you...
- Active or recent malignancy (within last 2 years)
- Pregnancy or breast-feeding
- Inability to provide informed consent
Research Team
P
Paul C Bogaardt, PhD(c), MSc, MBA
K
Karen Mulholland Angelus
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