In a major victory for advocates of innovative stem cell treatments, the United States District Court of Central California rejected the U.S. Government's motion for summary judgment against Drs. Mark Berman and Elliot Lander, California Stem Cell Treatment Center, and Cell Surgical Network. Specifically, the Court denied the Government's request for a permanent injunction against the use of fat-derived stromal vascular fraction (SVF).
This case turns on the interpretation of an exception to FDA regulations called the same surgical procedure exception, 21 C.F.R. 1271.15(b) ("SSP Exception"). The SSP Exception applies to establishments that remove human cells, tissues, or cellular or tissue-based products and implant such cells, tissues, or tissue-based products into the same individual during the same procedure. The defendant physicians offer a medical treatment during which fat tissue is removed from a patient, SVF stem cells are isolated and implanted back into the same patient. The Government alleges that the SVF Process does not qualify for the SSP Exception because tissue is removed, but only SVF stem cells are implanted back into the body. Under the Government's interpretation, Defendants would have to remove stem cells only, and then implant those same stem cells back into the patient to qualify for the exception. The Government argued that because the SSP Exception does not apply, Defendants are selling an unregistered drug. Defendants argued that the SVF Process is a surgical procedure in which SVF stem cells are removed from the patient (albeit as part of the tissue removed) and that those same SVF stem cells are implanted back in the patient. Because the SVF stem cells are unaltered before and after the procedure, the SSP Exception applies.
The Honorable Judge Jesus Bernal held that if, in fact, the cells implanted are unaltered during the procedure, Defendants' SVF Procedure would qualify for the SSP Exception. Because that issue was not before the Court on the Government's motion, the parties will proceed to trial and the defendants will offer evidence to show that SVF stem cells are not altered during the procedure.
The case is United States of America v. California Stem Cell Treatment Center, Inc., et al. Venable LLP represented the Rancho Mirage-based California Stem Cell Treatment Center and Cell Surgical Network and founders Drs. Mark Berman and Elliot Lander in the case. Venable partner Celeste Brecht served as lead counsel, with support from Matthew Gurvitz.
"We are very gratified that the court has upheld our right to prove the safety of this revolutionary new treatment. As surgery advances, surgeons now have the ability to dissect down to the cellular level. The ruling by the court protects the patient's rights to their own cells, the autonomy of surgical procedures regulated by the state medical boards, and the physician's right to practice medicine, and prevents threatening overreaches by our regulatory authorities," said Dr. Mark Berman.
"We are pleased that the court has found that our client's innovative treatment should be allowed further examination under the Same Surgical Procedure Exemption. We are confident that a full review of the evidence at trial will show that California Stem Cell Treatment Center's use of a patient's own unaltered tissue meets this exemption," said Ms. Brecht.