Health TrialsbyHealthPanel

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

ConditionsAutoimmune DiseasesCardiovascular DisordersDiabetes ComplicationsIntegumentary DiseaseMusculoskeletal DisordersNeurodegenerative DisordersNeurologic DisordersPulmonary DisordersSexual DysfunctionUrologic DisordersViral Illness
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Advanced Medical LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 and older

Ability to provide informed consent

Availability for follow up visits

Disqualifiers

Active or recent malignancy (within last 2 years)

Pregnancy or breast-feeding

Inability to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • PrimePro™/ PrimeMSK™

    Biological/Vaccine

    Injection via condition specific route of administration.

Treatment groups

5,000 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Arm 1: Autoimmune DiseasesExperimental treatment 1 intervention
Group B: Arm 2: Cardiovascular DisordersExperimental treatment 1 intervention
Group C: Arm 3: Diabetes ComplicationsExperimental treatment 1 intervention
Group D: Arm 4: Integumentary DiseaseExperimental treatment 1 intervention
Group E: Arm 5: Musculoskeletal DisordersExperimental treatment 1 intervention
Group F: Arm 6: Neurodegenerative DisordersExperimental treatment 1 intervention
Group G: Arm 7: Pulmonary DisordersExperimental treatment 1 intervention
Group H: Arm 8: Sexual DysfunctionExperimental treatment 1 intervention
Group I: Arm 9: Urologic DisordersExperimental treatment 1 intervention
Group J: Arm 10: Viral IllnessesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
2

Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.

Upper Extremity Outcome Instrument

Time frame
Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
3

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.

Time frame
Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
4

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.

Time frame
Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Advanced Medical LLC

Lead sponsor

HeartStem Institute

Collaborator

NuStem

Collaborator

Source ClinicalTrials.gov
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