Isolated cells were inoculated with growth factors; these were either autologous and/or approved recombinant current good manufacturing practice (CGMP)  products (or approved animal-derived products), and placed in a rotary incubating chamber at 37°C until the procedure. Bacteriological controls on the final cell therapy product were achieved through sterile processing.

Infraorbital, zygomatic, mandibular, and mental blocks were given with 2% lidocaine HCl and adrenaline 1:100000. An incision hole with an 18-gauge Nokor™ (Becton, Dickinson and Company, Franklin Lakes, NJ) needle was placed on each hemi-facial side at the lower lateral malar area. An 18-gauge Amar cannula (Miller Medical, Phoenix, AZ) was used to give a small depot amount of the ADSC matrix. This was done in multiple depths in a fan-shaped pattern from the single incision site to the infraorbital area, nasojugal groove, medial and lateral malar area, and marionette lines within 15 hours of tissue harvesting.

A detailed recording was carried out and the pertinent data of all seven patients who received the stem cell facelift consists of:

  • Patient 1: an 83-year-old male, diagnosed with osteoarthritis of the knees was given 12 cc of ADSC‑enriched adipose matrix on the left and 14 cc product volume in the right side of his face
  • Patient 2: an 83-year-old female, diagnosed with osteoarthritis and osteoporosis with neurological symptoms of impaired memory and imbalance was given 15 cc of ADSC-enriched adipose matrix on the left and 14 cc product volume in the right side of her face
  • Patient 3: a 50-year-old male, diagnosed with osteoarthritis and joint pain, was given 14 cc of ADSC-enriched adipose matrix on the left and 10 cc product volume in the right side of his face
  • Patient 4: a 72-year-old male, diagnosed with diabetes and kidney failure was given 10 cc of ADSC-enriched adipose matrix on the left and 10 cc product volume in the right side of his face
  • Patient 5: a 50-year-old female, diagnosed with diabetes was given 11 cc of ADSC-enriched adipose matrix on the left and 9 cc product volume in the right side of her face
  • Patient 6: a 41-year-old male, diagnosed with osteoarthritis was given 8 cc of ADSC-enriched adipose matrix on the left and 12 cc product volume in the right side of his face
  • Patient 7: a 75-year-old male, diagnosed with diabetes and kidney failure was given 7.5 cc of ADSC-enriched adipose matrix on the left and 7.5 cc product volume in the right side of his face.
Figure 3 Patient 1 — two-dimensional images over time. (A) Before stem cell facelift, (B) 2 months, and (C) 7 months post-procedure

Figure 3 Patient 1 — two-dimensional images over time. (A) Before stem cell facelift, (B) 2 months, and (C) 7 months post-procedure

Three-dimensional colourimetric analysis was done for all patients using the Vectra H1 camera and software to determine volume change. The Vectra H1 works by capturing 3D, high-quality photographs, during which time, two pictures are taken simultaneously from three different viewpoints eliminating the chance of error12. The Vectra enables replicable 3D results of the patients themselves over time.

The Vectra software is one of the standards for patient imaging analysis. Photos are taken before and after the stem cell facelift. The Vectra software measures the changes in surface, volume, and distance by overlapping 3D-landmarked ‘before’ and ‘after’ images. For more accurate data, a minimum of five landmarks in each hemisphere of the face is used. After registering both of the surfaces, differences of the distance are measured from one photo to another. On calculating the distance, the statistical data is automatically gathered by the software. The distance is measured by millimetres while quantifiable volume change is measured in millilitres (cc).

Results

Table 1

This study included seven patients (14 hemi-faces) comprising two females and five males, with a mean age of 64.72 ± 17.58 years. All patients who did not comply with 3D imaging were excluded in the study. Follow-up time was done from 24 hours until 7 months. The mean amount of stem cell matrix placed on the right side of the face was 10.57 ± 3.15 cc while on the left was 10.71 ± 3.45 cc. The Vectra volume changes were compared using the baseline 3D images taken prior to the procedure to those taken after the stem cell facelift procedures (Figure 1).

Superimposed comparative images of the seven patients at 24 hours showed mean volume gain 9.28 ± 1.68 cc on the left and 9.46 ± 2.38 cc on the right (Table 1). These volume changes were very close to the mean amount of stem cell matrix (10.64 ± 3.3 cc) injected during the procedure. Superimposed comparative images at 1 month showed mean volume loss of 65.29% on the left and 65.58% on the right hemi-faces (Table 1). This volume decrease was the combined resultant loss of both the ‘untaken’ matrix (adipose and fluid) transferred and the subsiding of inflammation.

There was a volumetric increase of 19.04% (left hemi‑face) and 25.97% (right hemi-face) from the second month images (Figure 2). Thereafter, there was a continued increase in mean volume (cc) through to the seventh month in both hemispheres among patients (Figures 3 and 4). Patients 3, 4, 5, and 7 (Figure 5) retained a mean volume of 5.3 ± 2.4 cc by the sixth month, which is a 102% volume change increase, while Patients 1, 2, and 6 showed a mean positive volume change of 113% (Table 1 and Figure 6). There was a continuous volumetric increase in mean volume from the first month to seventh month, with a 100.87% increase in volumetric change on the left facial hemisphere and 63.6% volume increase on the right facial hemisphere. Overall, there was an 83.2% volume improvement across all patients. This volume increase after the first month presents a stage when tissue regeneration and blood perfusion are at its peak.

Statistical analysis

Figure 4 Patient 1 — three-dimensional colourimetric analysis demonstrating areas of volume change (blue) over time. Between (A) 2 months and (B) 7 months post‑procedure. The 83 year-old male was very pleased with the results

Figure 4 Patient 1 — three-dimensional colourimetric analysis demonstrating areas of volume change (blue) over time. Between (A) 2 months and (B) 7 months post‑procedure. The 83 year-old male was very pleased with the results

Statistical analysis was used to determine the effectiveness of the stem cell procedure, and descriptive analysis of facial improvements among patients was assessed using Vectra 3D software. The 3D software gave an output on patients’ facial images with stretched skin distances, in millimetres, to measure facial improvements qualitatively. Changes in distances, defined as ‘volumes’, were quantified.

Wilcoxon signed ranks tests were used to determine whether there was a significant change in the distances before and after the procedure. Assuming a non-normally distributed data (n=7 patients), the study provided conclusions on a 95% certainty level, with 5% margin of error and 84% power efficiency to test the data. The percentage increase was proven statistically significant, having the first month as a baseline comparison with the sixth month result (Z=-3.2958, P=0.00096<0.05), indicating an effectiveness of the stem cell treatment on the facelift among the seven patients. This study used Statistical Product and Service Solutions (SPSS) (SPSS Inc., Chicago, IL) version 20.0 to output numerical results.