Lipogems® Ortho — adipose-derived stem cell therapy

Lipogems® is an Italian system for the mechanical processing of adipose tissue (lipoaspirate) without enzymes or cell culture. This is critical for compliance with EU Regulation 1394/2007 — Lipogems® is classified as a "minimally manipulated tissue" and does not require an ATMP licence. The output is a tissue product with an intact mesenchymal stem cell niche (~2.5 million MSCs/ml) and preserved stromal structure.

SVF (Stromal Vascular Fraction) is obtained by enzymatic (collagenase) processing of fat — the tissue is broken down into individual cells. This yields a higher MSC concentration but in the EU it falls under ATMP regulation (a GMP licence is required). Lipogems® uses mechanical processing without enzymes — MSC concentration is lower but their natural microenvironment is preserved, which is important for survival and function after implantation.

Standard sites are the lateral abdomen or the inner thighs. Under local anaesthesia (tumescent infiltration), a 3–4 mm puncture is made and 30–60 ml of fat is harvested with a thin mini-invasive liposuction cannula. Cosmetic effect — slight volume reduction in the harvest area, leaving only a small puncture mark.

From 30 ml of lipoaspirate, ~6–8 ml of final Lipogems® product is produced, containing 15–20 million mesenchymal stem cells. That is 100–500 times more than in even the most concentrated PRP. For comparison, BMAC from 60 ml of bone marrow yields ~2–5 million MSCs.

No. The entire procedure is performed under local (tumescent) anaesthesia. The patient remains fully conscious; light sedation is available if required. Duration 60–90 minutes. Followed by 30 minutes of observation and discharge home. The next day most patients return to their usual activities.

Unlike PRP, Lipogems® is usually performed once and produces a long-lasting effect of 2–5 years. A repeat procedure is only considered if symptoms return — not to enhance the first effect. The reason is that MSCs "engraft" and continue to modulate recovery for many months.

In the first 2–3 weeks, there is usually no improvement (the engraftment period); some patients even experience a temporary increase in pain (this is normal). After 4–6 weeks — improvement begins. After 3 months — a clear effect. Maximum effect — by 6–12 months. After 12 months a control MRI is performed to assess morphological changes (cartilage repair).

Yes. Lipogems® is one of the safest regenerative procedures and can be performed at any age. In older patients the number of MSCs in fat is reduced (compared with 30-year-olds) but their function is preserved. Age-related contraindications are the same as for local anaesthesia: decompensated cardiovascular disease, severe diabetes mellitus.

Compensated diabetes mellitus (HbA1c <8%), stable coronary artery disease, controlled hypertension are not contraindications. Decompensated forms are relative contraindications and require prior stabilisation by a specialist. COPD, decompensated heart failure during exacerbation — postpone the procedure.