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Stem Cell Therapy

Biocellular Stem/Stromal Therapy for Hair Loss (STRAAND Trial)

Phase 1 & 2

Waitlist Available

Led By Kenneth Williams, DO

Research Sponsored by Healeon Medical Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males with a diagnosis of Androgenetic Alopecia (AGA).

Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale.

Must not have

History of or active diagnosis of autoimmune disease or organ transplantation or immunosuppressive medication(s)

Untreated or uncontrolled thyroid disorder (abnormal TSH/free T4) or diabetes mellitus (HgbA1C > 8.0)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of using a biocellular mixture of emulsified adipose-derived tissue stromal vascular fraction (AD-tSVF) and high density platelet-rich plasma concentrate (HD- PRP) to treat androgenetic alopecia (AGA) and Female Pattern Hair Loss (FPHL).

Who is the study for?

This trial is for adults with hair loss due to Androgenetic Alopecia or Female Pattern Hair Loss, who haven't responded to previous treatments. Participants must be willing to maintain their hair and avoid pregnancy. Exclusions include those on certain medications, with scalp conditions, autoimmune diseases, recent cancer treatment, or significant health issues.

What is being tested?

The study tests the safety and effectiveness of injecting a biocellular mix into the scalp. It compares different combinations of high-density platelet-rich plasma (HD-PRP), adipose-derived stem/stromal cells (AD-tSVF and AD-cSVF), and MatriStem Matrix against a control group receiving standard care.

What are the potential side effects?

Potential side effects may include irritation at injection sites, allergic reactions to components used in the procedures, infection risk increase due to injections, and possible systemic reactions from biocellular materials.

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 male pattern baldness.

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I am a woman experiencing hair loss.

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I am a male diagnosed with male pattern baldness.

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I am a woman diagnosed with Female Pattern Hair Loss without any scarring or autoimmune conditions.

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I have been cancer-free and without treatment for 5 years with no signs of it coming back.

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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:

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I have an autoimmune disease, have had an organ transplant, or am on immunosuppressive drugs.

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I do not have untreated thyroid issues or diabetes with HgbA1C over 8.0.

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I have never had treatments for hair loss like transplants or laser therapies.

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I am on long-term antibiotics or steroids.

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I have tried a hair loss treatment before that didn't work for me.

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I have or might have conditions like scarring alopecia, lupus, or other issues affecting hair growth.

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I haven't taken any medication that affects bleeding or clotting in the last 2 weeks.

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I do not have any severe health or mental health conditions.

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I have had surgery in the area being considered for treatment.

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My scalp is sensitive, irritated, or has sores.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety-Tolerability Assess of SAE/AE Assessment of SAE/AES

Secondary study objectives

Global Photometric Scalp Hair

Hair Density Trichogram

Hair Growth Trichogram

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ARM 3Experimental Treatment7 Interventions

Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF; Intervention: Intradermal injections of hair loss 1. Platelet Rich Plasma 2. Adipose Derived Stem/Stromal Cells 3. Stem/Stromal Cell Isolation 4. Intradermal injections of hair loss

Group II: ARM 2Active Control5 Interventions

1. Experimental: HD-PRP + Emulsified AD-tSVF; Intervention: 2. Platelet Rich Plasma 3. Adipose Derived Stem/Stromal Cells 4. Intradermal injections of hair loss

Group III: ARM 1Active Control4 Interventions

Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Intradermal injections of hair loss 3) Platelet Rich Plasma 4) Matristem Matrix (ACell)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet Rich Plasma

2016

Completed Phase 4

~1100

0 / 16Eligibility criteria met