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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
STRAAND Trial 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.Check my eligibility
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.See study design
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.
STRAAND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a male diagnosed with male pattern baldness.
Select...
I am a woman experiencing hair loss.
Select...
I am a male diagnosed with male pattern baldness.
Select...
I am a woman diagnosed with Female Pattern Hair Loss without any scarring or autoimmune conditions.
Select...
I have been cancer-free and without treatment for 5 years with no signs of it coming back.
Select...
I am 18 years old or older.
STRAAND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety-Tolerability Assess of SAE/AE Assessment of SAE/AES
Secondary outcome measures
Global Photometric Scalp Hair
Hair Density Trichogram
Hair Growth Trichogram
+2 moreSTRAAND 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
Platelet Rich Plasma
Adipose Derived Stem/Stromal Cells
Stem/Stromal Cell Isolation
Intradermal injections of hair loss
Group II: ARM 2Active Control5 Interventions
Experimental: HD-PRP + Emulsified AD-tSVF;
Intervention:
Platelet Rich Plasma
Adipose Derived Stem/Stromal Cells
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Terry, Glenn C., M.D.INDIV
4 Previous Clinical Trials
400 Total Patients Enrolled
Ministry of Health, HondurasOTHER_GOV
3 Previous Clinical Trials
2,312 Total Patients Enrolled
Healeon Medical IncLead Sponsor
8 Previous Clinical Trials
650 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease, have had an organ transplant, or am on immunosuppressive drugs.I do not have untreated thyroid issues or diabetes with HgbA1C over 8.0.I am a male diagnosed with male pattern baldness.I have never had treatments for hair loss like transplants or laser therapies.I am a woman experiencing hair loss.I am on long-term antibiotics or steroids.Your blood tests show significantly low hemoglobin, liver or kidney problems, or abnormal blood clotting results.I am a male diagnosed with male pattern baldness.I am a woman diagnosed with Female Pattern Hair Loss without any scarring or autoimmune conditions.I am a male with moderate to severe hair loss.I am experiencing hair loss ranging from minimal to moderate.I am a male experiencing moderate to severe hair loss.I haven't used any hair loss treatments, including over-the-counter or herbal, in the last 12 months.I have tried a hair loss treatment before that didn't work for me.I have or might have conditions like scarring alopecia, lupus, or other issues affecting hair growth.I have had surgery in the area being considered for treatment.I do not have any health conditions that could worsen my overall health if I join the trial.My scalp is sensitive, irritated, or has sores.I have a condition other than cancer that causes hair loss.I am willing to keep my hair the same length and color.I have been cancer-free and without treatment for 5 years with no signs of it coming back.I am 18 years old or older.I am currently undergoing cancer treatment or have had cancer, except for treated skin cancer.I haven't taken any medication that affects bleeding or clotting in the last 2 weeks.I do not have any severe health or mental health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: ARM 2
- Group 2: ARM 1
- Group 3: ARM 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any additional participants being admitted to this medical experiment?
"According to the clinicaltrials.gov database, this particular medical trial has ceased recruitment at present time; it was originally posted on August 14th 2016 and last updated on August 1st 2022. However, there are still two other trials currently searching for patients as of right now."
Answered by AI
Who else is applying?
What site did they apply to?
Kenneth Williams, DO
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How many injections/visits?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Hair loss is not stopping. I've been experiencing hair thinning and hair loss and I would like to act before it gets too late.
PatientReceived 1 prior treatment
I had two hair transplants in 1999 and 2001 but have been wearing a hair peace since 2009. COVID made acquiring hair much harder and started trying to grow my hair back with limited success.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Kenneth Williams, DO: < 48 hours
Average response time
- < 2 Days
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