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Stem Cell Therapy

Stem Cell Therapy for Chronic and Acute Conditions

Phase 1 & 2
Recruiting
Led By Ernst R Von Schwarz, MD, PhD
Research Sponsored by Thomas Advanced Medical LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Awards & highlights

Study Summary

This trial is testing if stem cell therapy is safe and effective for treating various conditions. So far, results look promising.

Who is the study for?
This trial is for adults over 18 who can attend follow-up visits and give informed consent. It's not suitable for those with recent cancer history (within the last 2 years), pregnant or breastfeeding individuals, or anyone unable to consent.Check my eligibility
What is being tested?
The study tests stem cell therapies called PrimePro™/PrimeMSK™ on a range of conditions including musculoskeletal, neurological, skin diseases, cardiovascular issues, diabetes, neurodegenerative and lung diseases, autoimmune disorders, sexual dysfunction and viral infections.See study design
What are the potential side effects?
While specific side effects are not listed here, stem cell therapy may include risks such as infection at injection site, immune reactions to the cells used in treatment or failure of the cells to work as expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.
Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.
Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.
+5 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Arm 9: Urologic DisordersExperimental Treatment1 Intervention
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for urologic conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
Group II: Arm 8: Sexual DysfunctionExperimental Treatment1 Intervention
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for sexual dysfunction conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
Group III: Arm 7: Pulmonary DisordersExperimental Treatment1 Intervention
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for pulmonary disorders. Outcomes will be compared to results in peer-reviewed literature for several conditions.
Group IV: Arm 6: Neurodegenerative DisordersExperimental Treatment1 Intervention
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for neurologic and neurodegenerative disorders. Outcomes will be compared to results in peer-reviewed literature for several conditions.
Group V: Arm 5: Musculoskeletal DisordersExperimental Treatment1 Intervention
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for orthopedic and musculoskeletal conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
Group VI: Arm 4: Integumentary DiseaseExperimental Treatment1 Intervention
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for integumentary diseases and conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
Group VII: Arm 3: Diabetes ComplicationsExperimental Treatment1 Intervention
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for diabetes complications. Outcomes will be compared to results in peer-reviewed literature for several conditions.
Group VIII: Arm 2: Cardiovascular DisordersExperimental Treatment1 Intervention
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for cardiovascular disorders and conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
Group IX: Arm 1: Autoimmune DiseasesExperimental Treatment1 Intervention
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.
Group X: Arm 10: Viral IllnessesExperimental Treatment1 Intervention
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for viral illnesses. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Thomas Advanced Medical LLCLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
HeartStem InstituteUNKNOWN
1 Previous Clinical Trials
40 Total Patients Enrolled
NuStemUNKNOWN

Media Library

PrimePro™/ PrimeMSK™ (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04684602 — Phase 1 & 2
Diabetes Research Study Groups: Arm 4: Integumentary Disease, Arm 5: Musculoskeletal Disorders, Arm 7: Pulmonary Disorders, Arm 8: Sexual Dysfunction, Arm 9: Urologic Disorders, Arm 10: Viral Illnesses, Arm 1: Autoimmune Diseases, Arm 2: Cardiovascular Disorders, Arm 3: Diabetes Complications, Arm 6: Neurodegenerative Disorders
Diabetes Clinical Trial 2023: PrimePro™/ PrimeMSK™ Highlights & Side Effects. Trial Name: NCT04684602 — Phase 1 & 2
PrimePro™/ PrimeMSK™ (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684602 — Phase 1 & 2
Diabetes Patient Testimony for trial: Trial Name: NCT04684602 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are participating in this clinical trial?

"The clinical trial is listed as recruiting on clinicaltrials.gov and was originally posted on 7/9/2020. As of 4/27/2022, the study is looking for 5000 participants from 1 site."

Answered by AI

Are people being signed up for this clinical trial right now?

"Correct. The information available on clinicaltrials.gov reflects that this clinical trial is actively recruiting patients. This study was posted on 7/9/2020 and was last edited on 4/27/2022. They are looking to enroll 5000 patients from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

Need to find out a safe method in dealing with my condition. Willing to try testing to fix my problem, other than surgery.
PatientReceived 1 prior treatment
~3042 spots leftby Jul 2030