Rochester, NY — September 8, 2025 — Regenerelle®, a global leader in the manufacturing and distribution of Wharton’s Jelly Mesenchymal Stromal Cells (WJ-MSCs) and exosomes derived from WJ-MSCs, today announced the public release of its full response to the U.S. Food and Drug Administration (FDA) Untitled Letter dated May 22, 2023.
The disclosure is being made by AT Venture Center, the parent company of Regenerelle, LLC, the regenerative biotherapeutic manufacturing and distribution arm of the company providing stem cells and exosome products to its subsidiaries and distributors serving an extensive connected network of more than 4,000 regenerative medicine and aesthetics professionals worldwide, including MedSpas, orthopedic and pain clinics, wound care centers, and aesthetic practices.
FDA Inquiry and Regenerelle’s Response
In 2023, the FDA issued an Untitled Letter raising questions regarding Regenerelle’s authority to manufacture and distribute regenerative biotherapeutic products within the United States. At that time, Regenerelle operated as an FDA-registered, New York State–licensed tissue bank from its 6,600-square-foot cleanroom facility in suburban Rochester, NY.
Regenerelle promptly provided a comprehensive response that addressed all issues raised by the FDA. After review, the FDA confirmed no further action was required. To date, Regenerelle has had no subsequent correspondence from the agency.
Despite this, certain legal blogs and industry commentators mischaracterized the nature of the FDA’s inquiry, suggesting incorrectly that Regenerelle was in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) or the Public Health Service (PHS) Act. These claims were based solely on the existence of an Untitled Letter and not on the facts provided in Regenerelle’s detailed submission.
Key Findings from Regenerelle’s Response
- Compliance Confirmed: Regenerelle demonstrated to the FDA that it was not marketing unapproved drug or biologic products.
- Licensing Not Required: The company established that a biologics license or investigational new drug application was not legally necessary to distribute its products in the United States.
- Lawful Use Pathways:
- WJ-MSCs qualify as experimental medical-grade drug products available to physicians under President Obama’s 2016 expansions to the Expanded Access Program and President Trump’s 2018 Right to Try Act.
- Several state laws, including those in Utah and Florida, further support the use of regenerative products in orthopedic, pain management, and wound care settings.
- Exosome Classification: Regenerelle’s WJ-derived exosomes are recognized as exempt biological materials, defined under FDA guidelines as “secretions from cell factors,” and are an unmanipulated acellular nano-scale product that is classified as a non-human cells or tissues.
These findings confirm that Regenerelle remains fully compliant with federal and state requirements governing the manufacture and distribution of regenerative biotherapeutics.
Transparency and Industry Leadership
To provide clarity for physicians, patients, and industry stakeholders, Regenerelle is publishing the complete text of its FDA response on BioInformant, the world’s largest publisher of stem cell industry news. This step underscores the company’s commitment to transparency and to correcting misinformation in the public domain.
“Regenerelle has always operated with the highest standards of regulatory compliance, scientific rigor, and ethical responsibility,” said Professor Michael Crowley, JD, Co-founder, Chaitman and CEO spokesperson for The Crowley Center. “By releasing our FDA response publicly, we aim to ensure that our partners, clients and patients understand the strength of our position and the continued lawful availability of our industry “Gold Standard” medical grade products.”
The following is Regenerelle’s response to the aforementioned May 22, 2023 FDA untitled letter.
Dear Director Mendoza,
We are responding to the U.S. Food and Drug Administration (“FDA”) letter received by AT Venture Center for Global Techtrepeneurship, LLC, dated May 22, 2023, regarding the marketing of certain adult human mesenchymal stem/stromal cells (“MSCs”) (the “Untitled Letter”) and information you reviewed at www.regenerellestemcells.com/, www.atventurecenter.com/, and the YouTube channel, previously available at www.youtube.com/watch?v=SUeu0dcl7Yw.
As an initial matter, the letter was addressed to Michael C. Crowley, Chairman and Chief Executive Officer of AT Venture Center for Global Techtrepeneurship, LLC. For clarification, AT Venture Center for Global Techtrepeneurship, LLC has recently changed its name to Regenerelle, LLC (“Regenerelle” or the “Company”). AT Venture Center, a different entity from Regenerelle is a venture firm that invests in various life science companies, including Regenerelle, and is not a manufacturing firm.
I. Introduction
Founded in 2020, Regenerelle is a mission-oriented company, with a desire to advance science and bring ground-breaking technology to a wide range of research applications. Regenerelle is a biotechnology research company dedicated to providing an off-the-shelf, high quality, low passage Wharton’s jelly stem-cell product (along with exosomes) for applications in aesthetics. As part of this mission, Regenerelle also provides its Products for use in stem cell research.
Regenerelle manufactures and markets a line of human mesenchymal stem/stromal cells (“MSCs”) and exosomes derived from Wharton’s Jelly (the “Products”). Wharton’s jelly-derived cells are the industry “gold standard” for stem cell-based therapies because of a variety of favorable properties of the mesenchymal stem cells found only in umbilical cords. Regenerelle’s manufacturing facility, located in Fairport, New York is licensed by New York State as a Tissue Bank. 1, 2 The facility uses good tissue manufacturing practices (gTMPs), follows ISO 9001:2015 current Good Manufacturing Practices3 (cGMPs or GMPs), ISO 7 and ISO 5 current good manufacturing practices, and complies with the requirements set forth in 21 C.F.R. Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps). All calibrated equipment is audited annually by Ralph Kraft, a third-party auditor, accredited to ISO 17025:2017.4
II. Regenerelle’s Online Marketing
In response to the Untitled Letter, Regenerelle has made a variety of changes to its website www.regenerellestemcells.com (the “Regenerelle website”). These updates form a more accurate representation of Regenerelle’s business. For reference, the Company removed statements that make reference to “aging-associated diseases,” “conditions related to bones and aging,” “lupus,” “auto-immune diseases,” and the like.5
Also, the website now features a Confirm Pop-Up for physicians and researchers alongside a disclaimer which reads as follows:
Disclaimer: This Website is For Medical and Research Professionals Only. This website is intended to inform and educate medical professionals and researchers. It is NOT intended for patients or the general public. Regenerelle products have not been approved by the U.S. Food and Drug Administration for treatment or effectiveness.
Interested patients in the U.S. are advised to consult a physician about opportunities to participate in a clinical trial and Expanded Access Investigational New Drug Individual or Group Treatment Trials. Interested patients outside the U.S. should consult a physician in their specific country. By signing below, you confirm that you are a medical professional or researcher and that you have read and understood the disclaimer above.
Website visitors are not permitted access to the website content until interacting with the Confirm Pop Up.
The Regenerelle website also makes clear that (as discussed below) its Products are not available for direct purchase through its website. Rather, the Regenerelle website merely takes requests for more information and quotes from researchers and physicians who are looking for more information about the various Regenerelle Products.
As the website flow demonstrates, Regenerelle is not marketing to patients or other consumers. Regenerelle clearly describes its Order Process6 as follows:
Thank you for your interest in the Regenerelle Products. After filling out and submitting this order request form, a Regenerelle Product Expert will contact you to go over eligibility, product pricing, shipping details, and availability before the order is confirmed. If your request is urgent, please Contact us at (585) 484-0058 or Regenerelle@atventurecenter.com
Of course, Regenerelle requires a Physician Name and Clinic Name to accompany a request for more information.7 This information is then used by the Company to assess eligibility for the Products. If a request is submitted and upon review it is discovered that the physician or clinic is not eligible, Regenerelle will respond to the request with the following:
Thank you for your interest in the Regenerelle Products. Upon review of the information you submitted, we are unable to confirm your eligibility for the Regenerelle Products. If you believe this was done in error, please contact Regenerelle@atventurecenter.com and someone from our team will contact you shortly.
Lastly, the Regenerelle website provides that its Products are “MSC & Exosome Research Use Products For Research Professionals Only”8 and the Regenerelle Purchase Order Form disclaims that “Regenerelle’s products are for RESEARCH USE ONLY (RUO) by a clinician or researcher.”9 Regenerelle also revised portions of its website to describe the limited conditions under which it will participate in the Expanded Access or Right to Try programs, which is explained in greater detail below.
Of course, Regenerelle requires a Physician Name and Clinic Name to accompany a request for more information.7 This information is then used by the Company to assess eligibility for the Products. If a request is submitted and upon review it is discovered that the physician or clinic is not eligible, Regenerelle will respond to the request with the following:
Thank you for your interest in the Regenerelle Products. Upon review of the information you submitted, we are unable to confirm your eligibility for the Regenerelle Products. If you believe this was done in error, please contact Regenerelle@atventurecenter.com and someone from our team will contact you shortly.
III. Regenerelle’s Domestic Business Moving Forward
As discussed above, Regenerelle does not currently market its Products for domestic commercial consumption, and it has no plans to do so in the future absent the requisite FDA approval. Nonetheless, Regenerelle produces a variety of stem-cell and exosome Products in the ordinary course of its business that have potential research applications. Given its scientifically-oriented mission and the potential for such research projects to yield beneficial therapies for patients, Regenerelle intends to participate in legitimate and approved research endeavors moving forward.
The Federal Food, Drug, and Cosmetic Act (“FDCA”) allows for the shipment and use of drugs in interstate commerce in the context of approved investigational new drug applications (“INDs”).10 Regenerelle does not currently and does not intend to in the future sponsor its own INDs. Rather, it seeks to facilitate stem-cell research by providing its product to eligible researchers. Regenerelle understands that the IND submission, review, and approval process contains extensive safeguards, including that IND applications must contain details about the clinical protocols and investigators for the proposed clinical studies, supported by animal pharmacology and toxicology studies.11 The Company can ensure that its participation only includes sponsors who are conducting trials pursuant to an official FDA IND prior to making any sales for research purposes.
The FDCA also allows limited routes through which patients in dire need of unapproved therapies can access potentially life-saving treatments. Expanded Access (“EA”), for example, allows physicians to “request from a manufacturer or distributer . . . an investigational drug or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition.”12
Regenerelle understands that EA applications are subject to FDA approval, and FDA must determine that there is “no comparable or satisfactory alternative therapy available,” that “the probable risk to the person from the investigational drug . . . is not greater than the probable risk from the disease or condition,” that “there is sufficient evidence of safety and effectiveness to support the use of the investigational drug,” and that providing the drug would not interfere with the clinical investigation needed to obtain marketing approval. Id. Regenerelle intends to cooperate with physicians interested in using Regenerelle Products for EA, but it will only distribute Products once there is an approved EA application in place.
Similarly, Congress has recently codified a patient’s “Right to Try” unapproved drugs in certain circumstances. Eligible patients include those with life-threatening diseases whose physicians have certified that they have exhausted all approved treatment options and are unable to participate in a clinical trial.13 If Regenerelle’s Products meet the “eligible drug” definition under the Right to Try Act, the Company will provide its Products to physicians whose patients have no other options. Regenerelle would, in that event, of course comply with the reporting requirements contained in the Right to Try Act.14
IV. Conclusion
We appreciate your time and attention to this matter. Should you have any questions, please feel free to contact Michael Crowley at michaelcrowley@atventurecenter.com.
The foregoing letter fully and completely addressed the concerns raised by FDA respecting language that the FDA felt needed to be revised. The FDA letter did not, however, raise any concerns respecting the manufacturing, production or distribution Regenerelle’s Wharton’s jelly Mesenchymal Stromal (Stem) Cells (WJ-MSCs) or Exosomes (WJ-Exosomes).
Regenerelle’s WJ-Exosomes are an exempt biological material that is currently used very broadly by regenerative medical physicians in Utah, and as of July 1, 2025, Florida law now permit the treatment of patients for pain, orthopedics and wound. The FDA, as well as the Florida and New York laws, expressly permits the use of “secretions of cell factors” (aka exosomes)
About Regenerelle®
Regenerelle is one of the world’s leading manufacturers of Wharton’s Jelly Mesenchymal Stromal Cells (WJ-MSCs) and the largest global manufacturer of WJ-derived exosomes. Through its subsidiaries—including Resilielle (topical cosmetics), Age Zero Biotherapeutics (physician-prescribed inhalation therapies), Harragan’s Hair Restoration Centers, and Perpetuelle (injectables)—Regenerelle provides innovative regenerative solutions to thousands of clinics worldwide.
Copyright 2025, All Rights Reserved
The Crowley Center for Regenerative Biotherapeutics, LLC (Republished with Permission)
1 See Exhibit A – Current Regenerelle LLC Human Cell and Tissue Establishment Registration
2 See Exhibit B – Tissue Bank License from New York State
3 See Exhibit C – Certificate of Internal Audit Conducted by Linchpin Global LLC
4 See Exhibit D –Certificate of Internal Audit Conducted by Ralph Kraft
5 See www.regenerellestemcells.com/
6 See Exhibit E – Regenerelle Purchase Order Form
7 Id.
8 See Exhibit F – Research Use Only (RUO) Products Webpage
9 See Exhibit E – Regenerelle Purchase Order Form
10 21 C.F.R. § 312.3.
11 21 C.F.R. § 312.23(6)-(8).
12 21 U.S.C. § 360bbb(b).
13 See 21 U.S.C. § 360bbb-0a.
14 Id. at § 260bbb-0a(d).