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Clinics in Roseville, Minnesota

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Roseville, MN

Stem Cell Therapy clinics in Roseville

Roseville supports a regenerative medicine market shaped by both private clinics and regional academic medicine. Local referral networks run through Sutter Roseville Medical Center and Kaiser Permanente Roseville, and stem cell practice in the area spans Stanford Ranch, West Roseville, and the Galleria corridor. Patient demand splits across three buckets: orthopedic injections for active adults and aging athletes, neurological and autoimmune protocols marketed to longevity-focused patients, and IV-based allogeneic products offered by private wellness clinics. The FDA classifies most stem cell injections for orthopedic, neurological, or longevity use as investigational biologics under 21 CFR Part 1271, meaning they require either a Biologics License or an active Investigational New Drug authorization. Autologous bone marrow and adipose products may qualify as Section 361 when minimally manipulated and used for homologous function. SB 1004 (2017) requires written disclosure when stem cell therapy is not FDA-approved. The Medical Board of California regulates physician practice under Business and Professions Code 651. Proposition 71 (2004) established the California Institute for Regenerative Medicine (CIRM). The FDA secured a 2022 permanent injunction against the California Stem Cell Treatment Center over non-compliant adipose SVF products. The 3 Roseville clinics listed below have been reviewed against our vetting criteria, including federal NPI lookup, OIG exclusion screening, and California Medical Board licensure checks.

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Regulatory context

A note on Minnesota's stem cell therapy rules.

Minnesota cellular therapy is governed by 21 CFR Part 1271. Section 361 covers minimally manipulated HCT/Ps used for homologous use without premarket approval. Section 351 covers products that are more than minimally manipulated, used non-homologously, or combined with another article, and these require an IND for clinical use or a BLA for marketing. Most stem cell, stromal vascular fraction, and exosome therapies marketed in Minnesota for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. The state is also home to Mayo Clinic, which conducts substantial IND-based regenerative research.

  • Minnesota Medical Practice Act, Minnesota Statutes Chapter 147
    Establishes physician licensure and discipline through the Minnesota Board of Medical Practice.
  • Minnesota Pharmacy Practice Act, Minnesota Statutes Chapter 151
    Regulates compounding pharmacies aligned with federal 503A and 503B standards.
  • Minnesota Prevention of Consumer Fraud Act, Minnesota Statutes Section 325F.68 to 325F.70
    Empowers the Attorney General to pursue deceptive marketing claims against providers making unsupported clinical claims.

The FDA has corresponded with Minnesota providers offering cellular therapies, and warning letters have been issued to regional clinics with operations in or near Minnesota. The Minnesota Board of Medical Practice has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Minnesota Attorney General has used the Prevention of Consumer Fraud Act to pursue deceptive health marketing. Mayo Clinic's regenerative medicine programs operate under FDA-cleared INDs, providing a high-compliance benchmark in the state.

Sources: fda.gov · mn.gov · ag.state.mn.us

Stem Cell Therapy in Roseville, answered.

Most stem cell therapies at private Roseville clinics are not FDA-approved. The FDA has approved certain hematopoietic stem cell products for blood and immune disorders, but stem cell injections for orthopedic, neurological, or longevity use are generally investigational. They require a Biologics License or an active Investigational New Drug authorization, or they must qualify as Section 361 minimally manipulated and homologous-use products under 21 CFR Part 1271. SB 1004 (2017) requires written disclosure when stem cell therapy is not FDA-approved.

Roseville sits in the premium metro tier. Single-joint autologous bone marrow or adipose injections typically run $5,000 to $15,000 per session. Systemic IV protocols using allogeneic umbilical cord or Wharton's jelly products range $10,000 to $25,000, and full multi-session protocols can reach $20,000 to $50,000. Exosome add-ons range $4,000 to $8,000. Insurance rarely covers these treatments because the FDA classifies most protocols as investigational.

Autologous stem cells come from your own body, usually harvested from bone marrow aspirate or adipose tissue and reinjected the same day. When minimally manipulated and used for homologous function, they often fall under FDA Section 361, which does not require pre-market approval. Allogeneic stem cells come from a donor source, most commonly umbilical cord blood or Wharton's jelly, and are generally classified as Section 351 biologics that require an active Investigational New Drug authorization. Roseville clinic offerings span both categories, so ask which classification applies before treatment.

Yes. Research programs at Sutter Roseville Medical Center and Kaiser Permanente Roseville periodically run FDA-authorized stem cell trials across orthopedics, neurology, cardiology, and oncology. Search clinicaltrials.gov and filter by Roseville or the broader metro to see active recruiting studies. Trial participation is typically low-cost or free compared to commercial protocols and includes structured follow-up with imaging and lab monitoring.

Verify physician licensure through the California Medical Board and confirm the clinic's NPI number through the NPPES registry. Check the FDA warning letter database for the clinic name and the HHS Office of Inspector General exclusion list. Ask whether the treatment is Section 361 or Section 351, whether the clinic operates under an Investigational New Drug authorization for allogeneic or expanded products, and whether adverse events are tracked. Ask specifically about compliance with SB 1004.

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