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Cellular Regenerative Treatment

Cell + Plasma Therapy for Hair Loss (SAAA Trial)

N/A
Recruiting
Led By Ken Williams, DO
Research Sponsored by Regeneris Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males with a biopsy proven diagnosis of Scarring alopecia (SA) or Alopecia Areata (AA)
Males with a biopsy proven diagnosis of a Scaring alopecia (SA) or Alopecia Areata (AA)
Must not have
Previous failure or deemed non-responsive to a previous experimental hair loss treatment
History of or active diagnosis of systemic autoimmune disease or organ transplantation or immunosuppressive medication(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new mixture of cells and plasma to see if it is safe and effective in treating hair loss. The mixture will be compared to a similar mixture and to a control group who will receive a standard treatment.

Who is the study for?
This trial is for adults over 18 with a biopsy-confirmed diagnosis of Scarring Alopecia or Alopecia Areata. Participants must be able to complete surveys and photo documentation, have been cancer-free for at least five years, and not use hair loss treatments within the last year. Women must test negative for pregnancy and agree to use two forms of contraception.
What is being tested?
The study tests the safety and effectiveness of different combinations of adipose-derived tissue stromal vascular fraction (AD-tSVF), platelet-rich plasma concentrate (HD-PRP), and cellular Stromal Vascular Fraction (AD-cSVF) in treating scarring alopecias and alopecia areata compared to established clinical protocols.
What are the potential side effects?
Potential side effects may include scalp irritation or reaction at injection sites, increased risk of bleeding due to PRP's effect on clotting, possible allergic reactions to treatment components, or other unforeseen complications related to the interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a male diagnosed with Scarring Alopecia or Alopecia Areata.
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I am a male diagnosed with Scarring Alopecia or Alopecia Areata.
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I am 18 years old or older.
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I am a woman diagnosed with Scarring Alopecia or Alopecia Areata.
Select...
I have been cancer-free and without treatment for 5 years with no signs of it coming back.
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I am a woman diagnosed with Scarring Alopecia or Alopecia Areata.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have tried a hair loss treatment before that didn't work for me.
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I have an autoimmune disease, had an organ transplant, or am on immunosuppressive drugs.
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I do not have an active infection.
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I am on long-term antibiotics or steroids.
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I am not taking any medication that affects bleeding or clotting, nor do I have any disorders related to these.
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I do not have any severe medical or mental health issues.
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My scalp is sensitive, irritated, or has sores.
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I have had surgery in the area being considered for treatment.
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I have untreated or uncontrolled thyroid issues or diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of Intervention
Secondary study objectives
Hair Growth Assessment
Investigator Satisfaction Survey
Patient Satisfaction Outcome Survey
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: cSVF in Normal Saline IV ARM 4Experimental Treatment3 Interventions
cSVF + Normal Saline IV (500 cc) Infusion
Group II: Emulsification tSVF + PRP ARM 2Experimental Treatment3 Interventions
HD-PRP + Emulsified AD-tSVF; Intervention: Platelet Rich Plasma Concentrate
Group III: Emulsification tSVF + PRP + cSVF ARM 3Experimental Treatment4 Interventions
tSVF; PRP; cSVF cell enriched biocellular therapeutic mix
Group IV: Control ARM 1Active Control1 Intervention
Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Platelet Rich Plasma Concentrate)

Find a Location

Who is running the clinical trial?

Global Alliance for Regenerative MedicineOTHER
4 Previous Clinical Trials
700 Total Patients Enrolled
Regeneris MedicalLead Sponsor
3 Previous Clinical Trials
620 Total Patients Enrolled
Robert W Alexander, MDStudy DirectorGARM-USA
6 Previous Clinical Trials
810 Total Patients Enrolled
Ken Williams, DOPrincipal InvestigatorIIMSC

Media Library

cSVF in Normal Saline IV (Cellular Regenerative Treatment) Clinical Trial Eligibility Overview. Trial Name: NCT03078686 — N/A
Alopecia Areata Research Study Groups: cSVF in Normal Saline IV ARM 4, Emulsification tSVF + PRP + cSVF ARM 3, Control ARM 1, Emulsification tSVF + PRP ARM 2
Alopecia Areata Clinical Trial 2023: cSVF in Normal Saline IV Highlights & Side Effects. Trial Name: NCT03078686 — N/A
cSVF in Normal Saline IV (Cellular Regenerative Treatment) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03078686 — N/A
Alopecia Areata Patient Testimony for trial: Trial Name: NCT03078686 — N/A
~1 spots leftby Jan 2025
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