An interventional study of tSVF by lipoaspiration and PRP Concentration in Alopecia Areata and Scarring Alopecia, sponsored by Regeneris Medical. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-16.
Sponsored by Regeneris Medical · Not applicable, Interventional, and Treatment
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Among 98 studies in Alopecia Areata with a site in United States — 21 open to participants now, 32 under way, 8 of them phase 3. Alopecia Areata · United States.
Among the 98 studies in Alopecia Areata with a site in United States, this one is the 35th largest by planned enrollment of the 84 interventional ones that give a count, is one of 3 that started in 2017, is one of 10 with no phase, reaches primary completion later than 1 of the 31 other live ones, and was the 32nd registered.
220 studies on the registry are indexed under Alopecia Areata; 61 are open to participants now.
Browse Alopecia Areata studies →21 of the 98 studies in Alopecia Areata with a site in United States are open now. Recruiting first, the newest first:
AbbVie · Sites in United States, Australia, Japan and 1 more country
Ages 6–17
Pfizer · Sites in United States, Canada, China and 2 more countries
Ages 12+
Eli Lilly and Company · Sites in United States, Canada, China and 4 more countries
Ages 18–60
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 12+
Almirall, S.A. · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 41 Alopecia Areata studies recruiting now, 16 (39%) set no upper age limit and 21 (51%) stop at 75 or younger; 20 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
98 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 48 · Phase 3 16 · Phase 4 8
First in 1997; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 50 across 171 interventional studies indexed under Alopecia Areata.
Median enrollment 46 across the 84 interventional studies, 2,300 across the 14 observational. Of the 60 that completed or were terminated, 42 (70%) have results posted.
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52 of 98 have an industry lead sponsor. The 10 most frequent:
Regeneris Medical is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Regeneris Medical has 1 study filed under Alopecia Areata — fewer than ten, so there is no comparison to draw.
10 of the studies in Alopecia Areata with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07029711Phase 3PfizerA Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata | 2026-12-02 |
| NCT03898479Phase 3Sun Pharmaceutical Industries, Inc.Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata | 2027-05 |
| NCT06826196Aldena TherapeuticsA Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata | 2026-11 |
| NCT07821216PfizerReal-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data | 2026-11-20 |
| NCT06602232Dren BioA Study of DR-01 in Subjects With Alopecia Areata and Vitiligo | 2027-05 |
Add all 10 to your calendar (.ics) → With an account.
Among the 98 studies in Alopecia Areata with a site in United States, from their registry updates:
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The primary objective of this study is to evaluate the safety and efficacy of the use of a biocellular mixture of emulsified adipose-derived tissue stromal vascular fraction (AD-tSVF) and high density platelet-rich plasma concentrate (HD- PRP). Additionally, comparison with clinical outcomes of adipose-derived cellular Stromal Vascular Fraction (AD-cSVF) + AD-tSVF + HD PRP; AD-cSVF + emulsified AD-tSVF + HD- PRP; emulsified AD-tSVF + HD PRP + AD-cSVF; AD-cSVF via intravenous infusion in treatment of Scaring Alopecias and Alopecia Areata. Control will be served by use of established clinical protocol of using platelet concentrates with Matristem Matrix (Acel) injected in the same fashion as the other ARMs within this study, and comparative analyses performed at the endpoint of this study.
The aesthetic surgical \& cosmetic discipline of hair restoration is rooted in numerous landmark studies and progressive medical science in the medical literature. With the advent of advanced theories and science using cellular and platelet-derived growth factors within the scope of regenerative medicine, have been well established in a number of peer-reviewed publications, The use of biological modalities, e.g., HD-PRP concentrates (defined as > 4-6 times patient circulating baselines), have become recognized in a number of disciplines, including value of stimulation of scalp tissues and hair follicles in androgenetic alopecia (AGA). (See Clinical Trial Study STRAAND). A "retrograde" filling technique creating a potential space and subsequently injecting into this space will insure uniformity of placement and spread of the delivered treatment modality.
This study design is intended to be a prospective, randomized, multi-center trial with blinding of outcomes for independent observers, clinical provider, and patient observation/satisfaction study comparatives. The study proposes adipose-derived cellular and stromal components when mixed with platelet high density concentrates (HD-PRP) offers an advantage to produce a markedly more effective therapeutic profile in in treating patients with scaring alopecia's (SA) and alopecia areata (AA), tissue age related senescence, and encourage vascular capabilities by stimulation of vasculoneogenesis. The benefits of using autologous adipose-derived stem \& stromal cell (ADSC) populations are cell proliferation and vasculogenesis that is intrinsically linked with native inflammatory modulation and immunomodulatory capacities. Reports describing the safety and efficacy of this biocellular combination have been reported in peer reviewed literature.
In the second and third arms of this study, use of regenerative protocols currently being extensively been utilized in the treatment of degenerative musculoskeletal conditions and plastic surgical procedures have been safely and effectively employed. These protocols feature the use of an emulsified AD-tSVF + HD PRP (ARM 2) compared to use of emulsified AD-tSVF + AD-cSVF (cell enrichment) + HD PRP (ARM 3) containing the full heterogeneous stem/stromal cell population and its native bioactive matrix. Addressing regions of scalp dermis containing the microenvironment (niche) of the hair follicle, progenitor tissues ("bulge").
In ARM 3, addition of cellular enrichment of the emulsified AD-tSVF is accomplished via a semi-automated, closed sterile system (Healeon CentriCyte 1000 system) which effectively isolates and concentrate the cellular elements. The AD-cSVF is then mixed with high-density platelet rich plasma (HD-PRP) concentrates with emulsified AD-tSVF tissues prior to targeted scalp injections. This injected cell-enriched product contains the bioactive native adipose tissue scaffolding, autologous HD-PRP, and cell-enriched adipose stem/stromal cellular concentrations of stromal/stem cells.
In ARM 4 of this study, the addition of intravenous cellular deployment of isolated cSVF is performed following without direct injection to scalp sites. Observations in other trials have suggested that increased hair growth in shaft size, coloration and speed is noted in the majority of parenterally treated patients as an observed effect of infusions. In the future, clinical trial extension of this study will combine both the components shown in ARM 3 and add a concomitant ARM 4 to evaluate potential of stimulation of proliferative and regenerative potentials in the form of combined therapy.
It has been noted by several investigators that parenteral us of AD-cSVF has had an unexpected outcome of improve hair growth and color change. All of the study ARMs (with exception of comparative control ARM 1) are tested by flow cytometry for viabilities and numbers, which will be statistically compared to outcomes following the study completion to examine whether a statistically significant difference in results follows with each ARM can be shown.
The goal of this study is to demonstrate the safety and efficacy of each ARM. Biocellular injections into the scalp of men and women with a diagnosis of scaring alopecias and alopecia areata, with full reporting of AE and SAE (adverse events). In the intradermal injection portions of the study, the biocellular material is injected 3-5 mm in depth within the mid-reticular dermis to upper subcutaneous fat layer of the scalp. Placement of the biocellular and cell-enriched biocelluar is intended to examine changes associated with changes of the miniaturized hair follicle. It is hypothesized that delivery a milieu of stroma and stem/stromal cells will facilitate regenerative changes of the treatment sites. In addition to providing native bioactive tissue scaffolding, and a greater number of stromal/stem cells to the tissues surrounding the follicular niche will result in a positive effect.
Use of small needles for delivery is made possible with incorporating the novel use of emulsification of adipose tissue complex (lipoaspirates) This emulsified AD-tSVF and HD PRP methodology reduces surgeon injection pressure requirements resulting with use of smaller gauge needles. When clinically compared to the use of much larger needles required to inject non-emulsified AD-tSVF, it is an improvement on current techniques. A "retrograde" filling technique creating a potential space and subsequently injecting into this space the biocellular material as the needle is withdrawn is advanced in this study.
Successful stem/stromal cell-enrichment of AD-tSVF and HD PRP biocellular mixture has been reported in numerous peer-reviewed and published clinical experiences of injections for structural tissue augmentation in plastic surgery, chronic wound therapies, and ultrasound guided musculoskeletal treatments in orthopedic \& sports medicine.
Standard venipuncture for obtaining circulating whole blood is concentrating platelet components to create a low hematocrit HD-PRP using FDA approved E USA) Emcyte II following manufacturer's guidelines. Small volume closed syringe microcannula lipoaspiration is used to acquire AD-tSVF tissues(Tulip Medical GEMS, San Diego, CA,, followed by emulsification via the Healeon ACM System (Newbury Beach, CA, USA. Cellular testing of samples in Arm 2-4 will be performed by flow cytometry (ORFLO, MoxiFlow, Ketchum, ID, USA) for viability and cell concentrations.
A detailed patient medical history, study informed consent, and screening evaluations will determine eligibility and candidacy for the study and complying with the inclusion/exclusion criteria.
Recording of the platelet pre-operative measured baselines and achieved HD PRP concentrates, flow cytometric examination of cell viability, and cell counts of AD-cSVF should be completed on each patient. Biocellular injections and treatment will be given on two (2) separate procedures three (3) months apart. Follow up clinical examinations are to be performed at 6 months and 1 year period with completion of outcomes analyses including independent observer, clinician, and subject satisfaction. The volume of the therapueutic mix will be the standardized in volume for all trial ARMs.
Immediate reporting to the study group for all AR and SAR will be documented and recorded for the safety records directly to Ken Williams, DO, as Co-Principal Investigator. This Clinical Trial will have a sample size of 60 patients at up to six (6) centers utilizing this protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Exclusion Criteria:
Clinically significant abnormal findings on laboratory screening panels:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Platelet Rich Plasma Concentrate)
Procedure: PRP Concentration
HD-PRP + Emulsified AD-tSVF; Intervention: Platelet Rich Plasma Concentrate
Procedure: tSVF by lipoaspiration · Procedure: PRP Concentration · Procedure: Emulsification tSVF
tSVF; PRP; cSVF cell enriched biocellular therapeutic mix
Procedure: tSVF by lipoaspiration · Procedure: PRP Concentration · Procedure: Emulsification tSVF · Procedure: cSVF isolation and concentration
cSVF + Normal Saline IV (500 cc) Infusion
Procedure: tSVF by lipoaspiration · Procedure: cSVF isolation and concentration · Procedure: cSVF in Normal Saline IV
Lipoaspiration Harvest tSVF closed syringe microcannula harvest, Tulip GEMS microcannula syringe system
Preparation of High Density PRP Centrifugation per manufacturer directive, Emcyte II PurePRP System
Preparation of emulsified tSVF harvested adipose; Use of ACM Device; Micronization of tSVF through Sterile Screen
Healeon Centrifuge (CC1000) enzymatic digestion, incubation, isolation and neutralization to prepare cSVF concentrates
cSVF + NS for IV Placement
Safety of Intervention
Assess Adverse Events \& Severe Adverse Events
Time frame: 6 months
Hair Growth Assessment
Trichogram Assessment Hair Growth
Time frame: 12 months
Photographic Assessment Scalp Hair
lobal Photographic Assessment of Scalp Hair
Time frame: 12 months
Investigator Satisfaction Survey
Treating Investigator Outcome Survey
Time frame: 12 months
Patient Satisfaction Outcome Survey
Patient Assessment of Outcome
Time frame: 12 months
Plan to share: Undecided
Started Feb 2017 (actual). Primary completion is estimated for Jan 2025, 95 months after the start.
Of 21 interventional studies with no phase under Alopecia Areata, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 95 months is above that.
How these figures are worked out, and which studies are left out of them.
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