← Back to Search

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

SAAA Trial 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.Check my eligibility

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.See study design

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.

SAAA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a male diagnosed with Scarring Alopecia or Alopecia Areata.

Select...

I am a male diagnosed with Scarring Alopecia or Alopecia Areata.

Select...

I am 18 years old or older.

Select...

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.

Select...

I am a woman diagnosed with Scarring Alopecia or Alopecia Areata.

Select...

I am 18 years old or older.

SAAA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of Intervention

Secondary outcome measures

Hair Growth Assessment

Investigator Satisfaction Survey

Patient Satisfaction Outcome Survey

+1 more

SAAA 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)

0 / 7Eligibility criteria met

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

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

Frequently Asked Questions

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

Are participants under four decades of age accepted in this research?

"This clinical trial is looking for participants between the ages of 18 to 75. Separately, there are 16 studies that focus on minors and 86 trials specifically listing those over 65 as eligible candidates."

Answered by AI

To what extent is the participant pool for this research expanding?

"Affirmative. Clinicaltrials.gov indicates that this research trial, initially posted on February 17th 2017, is currently recruiting participants. Approximately 60 volunteers need to be sourced from 3 different locations."

Answered by AI

Is enrollment currently open for this investigation?

"This clinical trial is still recruiting participants. It was initially listed on February 17, 2017 and its information has been modified as recently as April 15th of 2020 according to the data available on clinicaltrials.gov."

Answered by AI

Who qualifies to join this investigation?

"This medical study is searching for 60 participants, ranging from 18 to 75 years old, who are currently living with alopecia areata. Additionally, the selected patients must have a biopsy-confirmed diagnosis of scarring alopecia or alopecia areata (for females only), no cancer history within 5 years prior and be willing to maintain their hair length and colour throughout the trial. Furthermore, women of childbearing age need to take a pregnancy test before being accepted into this clinical trial and agree to follow two forms of contraception during its duration."

Answered by AI