Who Can Participate In This Study?
Ages Eligible For Study: 18 Years and Older
Genders Eligible For Study: Male and Female
Accepting Healthy Volunteers: No
What Do I Need To Know About This Study?
APPROXIMATELY 60 subjects will take part in this study, and the entire study will last for approximately one (1) year. Follow up examinations and questionnaires will be provided to you at intervals during the study period. This is a PATIENT FUNDED study and up to two (2) treatments might be required.
Your participation in the study will be limited to the time needed for your intake interview, medical history and physical exam; actual biocellular treatment, and for follow-up times deemed necessary and appropriate to comply with the study.
In the event you have questions or an unexpected adverse event (e.g., higher level of discomfort, etc.), you are advised to contact the treating physician's office and report it. None of the tissues or samples obtained from you to participate in this study will be used for any clinical treatment or procedure on ANY other individuals.
ARM 1 (20 Patients): HD (High Desnsity) PRP +
Matristem Matrix (Acell)
ARM 2 (20 Patients): Experimental Emulsified AD-tSVF
+ HD PRP Concentrates
ARM 3 (20 Patients): Experimental AD-tSVF +
HD PRP Concentrates + AD-cSVF
How Do I Know If I Qualify?
To be contacted by a research team member in your area, please fill out the FORM below. This is a Patient Funded study, and up to two (2) treatments might be required.
Objective Of This Study
The STRAAND study represents Stromal Tissue Cell-enriched treatment of Androgenic Allopecia via Novel Deployment. The primary objective of this study is to evaluate the safety and efficacy (how well it works) of cell-enriched Biocellular Regenerative Therapy, which is a combination of tissues from your own body in the treatment of androgenetic alopecia (AGA) and Female Pattern Hair Loss (FPHL). This combination is accurately placed in the areas of hair loss and degenerating areas. The clinical condition will be closely followed and improvement documented.
Design of this study is intended to be a prospective, randomized, multicenter trial with blinding outcomes for independent observer, clinical provider and patient observation/satisfaction. If you have been diagnosed with AGA or FPHL, we hope that you will consider participating in the AGA biocellular study.
Hair Loss affects up to 70% of men and 40% of women in their lifetimes. Are you currently suffering from hair loss? The STRAAND Study might help you turn back time.
What Is AGA?
According to the National Institute of Health (NIH), Androgenetic Alopecia is the most common form of hair loss in both men and women. This form of hair loss affects an estimated 50 million men and 30 million women in the United States and can start as early as a person's teens, with risk increasing with age.
What Is Being Studied?
Men and Women with some degree of hair loss in their lifetime, which can commence in their early twenties. Androgenetic Alopecia (AGA) or common male pattern baldness (MPB), and Female Pattern Hair Loss (FPHL) accounts for more than 95% of hair loss in men and women.
For most men, a byproduct of testosterone metabolism called dihydrotestosterone (DHT) is the primary substance responsible for miniaturization of the hair follicle and subsequent balding. The causes of FPHL in women are varied, so prior to treatment, female patients require more investigation and workup compared to their male counterparts.
FDA-approved non-surgical treatments for AGA and FPHL involve the use of therapies that:
Induce the follicular growth phase (with the medication minoxidil)
Inhibit the conversion of testosterone to dihydrotestosterone (DHT) (with the medication finasteride)
Induce hair growth through complex intracellular mechanisms (with Low Laser Light Therapy (LLLT) devices)
The primary mechanism for hair loss has not yet been clearly established. Miniaturization of the hair follicle is the clinical hallmark of balding in men and women. Certain studies have established that stem cells residing in the scalp remain at persistent numbers, but the conversion of stem cells to the progenitor cells required for follicle regrowth and cycling is reduced in balding patients. Efforts to assist in the regeneration of the hair follicle may induce a more robust and stronger recycling of the hair follicle.
ABOUT THIS STUDY
What Are The Potential Risks and Benefits of Participating In This Study?
Potential Benefits Include:
Possible access to and care from leading doctors and researchers.
Reduced cost for regenerative therapy study treatment.
The use of the existing biocellular regenerative protocol has been successfully employed for more than 10 years in plastic surgery, pain management, and orthopedic and musculoskeletal injuries; and more than 20 years within aesthetic & reconstructive procedures by cosmetic plastic surgeons. The purpose of this controlled study is to determine whether cell-enriched biocellular targeted placement is equal to, or better than, other regenerative therapies that are not cell-enriched.
The potential benefits of stromal vascular fraction deployment for eligible patients may include improvement in certain chronic degenerative diseases. Although some benefits often occur, some patients will experience all of them, some will experience some of them and some patients will not experience any of them. Also, the degree of benefit varies from one patient to another.
Contribute to research that may improve the lives of others.
Potential Risks Include:
Overall incidence of complications or outcomes requiring additional attention are considered very low based on several years of experience with the use of Biocellular treatments.
Minor risks associated with needle insertions (blood draw and scalp injections) include discomfort, infection, bruising, tenderness of the site for a few hours/days, lymph node tenderness, fever, myalgias, allergy to medication or tape, minimal bleeding or drainage, hematoma collection (blood accumulation under the skin), local nerve injury are rarely, but occasionally encountered as a result of such injections. Side effects are typically resolved over 1-2 weeks.
Use of sterile, closed system disposable or sterilized cannulas may result in mild-moderate discomfort, small spot scarring from injection sites, infection, bruising, mild bleeding or drainage, embolism of fat or blood, hematoma or seroma (serum accumulation at site), minor surface irregularities, numbness of skin surface (usually transient).
Allergic reactions to administered medications; use of tape or latex may include anaphylactic shock, brain damage or death in very rare circumstances.
In addition to the risks or discomforts listed above, there are also unknown long-term effects of autologous stromal vascular fraction therapy.
Emboli, possible stroke or other similar event.
Other possible risks could include potentially harmful reactions to resuscitative medications or measures (chest compressions, electrical shock, CPR in general, and/or call 911) in the event of a life threatening reaction is encountered and requires treatment.
If you have an active tumor or cancerous tumor that is present but you are not aware of its existence, we do not know how it would be affected - it could conceivably be made more aggressive.
FAQ'S ON CLINICAL TRIALS
What Is A CLINICAL TRIAL?
A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find potential treatments that work in people and improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies, are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. (CISCRP, 2003).
What Happens During A CLINICAL TRIAL?
The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
How Is The Safety Of The Participant Protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scienfic meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
Does A Participant Continue To Work With A Primary Health Care Provider While In Trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Can A Participant Leave A Clinical Trial After It Has Begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Ken L. Williams, D.O., FISHRS
Irvine Institute of Medicine and Cosmetic Surgery
15785 Laguna Canyon Road, Suite 390
Irvine, CA 92618
Robert Alexander, M.D., DMD
Bitterroot Aesthetic & Reconstructive Surgery
7715 Main Street, Suite B
Stevensville, MT 59870
Ryan Welter M.D., Ph.D.
New England Center for Hair Restoration and
465 S Washington St
North Attleborough, MA 02760
Robert Niedbalski, D.O.
Northwest Hair Restoration
1201 Pacific Avenue, Suite 1910
Tacoma, WA 98402
Marco N Barusco, MD, FISHRS
Founder & Medical Dir - Tempus Hair Restoration, PA
Ass't Professor of Surgery - UCF College of Medicine
Diplomate & President (2017) - American Board of Hair Restoration Surgery (ABHRS)
Fellow - International Society of Hair Restoration Surgery (ISHRS)
Past-President (2012-2014) - American Society of Hair Restoration Surgery (ASHRS)
Port Orange Office:
5537 S. Williamson Blvd, Suite 752
Port Orange, FL 32123
Phone: 1-877-877-5200 - Fax: 1-888-877-5200