Adipose Tissue-Derived Stem Cells with PRP In Joints
Adipose Tissue-Derived Stem Cells with PRP In Joints
From November 18, 2009 until December 17, 2010, a total of 100 joints were treated in 91 patients. As of October 2012, the mean follow-up time for all patients was 26.62 ± 0.32 months. 100 procedure follow-up contacts occurred at 12 months or more, 78 contacts at 24 months or more, and 17 contacts at 30 months (Table 1). The first patient was treated on November 18, 2009. Thus, the follow-up time for patients who were treated in 2009 and early 2010 was close to three years.
There were a total of four patients in 2009. They were all female and their age was 61, 57, 71, and 77, respectively. Of these four, the first patient received two injections of ADSCs into the knee: the first dose was injected on November 18, 2009, and the second dose was injected on April 28, 2010. The first dose of the first patient did not include PRP. Thus, the procedure was repeated on April 28, 2010 with PRP and ADSCs. Of the total of 91 patients, three patients received two treatments of identical joints and six patients received two treatments at different joints. Nine patients underwent two procedures. Of the nine, three patients received ADSCs on the same knee joints and the other six patients received ADSCs on the other knees. The second procedure of all nine patients occurred with 3 ~ 4 months after the first. Of these nine patients, only one patient did not obtain MRI after the first and second doses of ADSCs. All other eight patients obtained MRI after three months from each first and second ADSCs/PRP treatment. Thus, the total number of joints treated (n = 100) is higher than the number of patients (n = 91) treated. The mean age was 51.23 ± 1.50, with the range being 18–78 years; 45 patients were male and 46 female. The age of patients was relatively evenly distributed (Table 1). Nine patients underwent more than one procedure. In all, the patients underwent 74 knee procedures (distributed with 67.6% in the age range of 40 ~ 69), 22 hip procedures (distributed with 81.8% in the age range of 18 ~ 49), two low back procedures, and two ankle procedures (Table 2). Of the 22 hip procedures, 15 were avascular necrosis and seven were hip osteoarthritis. All 74 knees and two ankles had diagnosis of osteoarthritis while the two low back procedures had spinal disc herniation.
Pre-procedure MRIs were carried out on 86 patients. Among these, 27 patients also underwent post-procedure MRIs. Due to financial reasons, 59 patients refused to undergo post-procedure MRIs. Mean time for last MRI follow-up since the procedure was 3.11 ± 0.12 months. MRIs (as read by both examiners and physicians) were negative for any evidence of tumor formation at the implantation site.
To assess the symptom improvement of the treatment, VAS was analyzed. For all patients, VAS was marked at 10 before treatments. The patients were followed up consequently with VAS at one month and at three months after the initial injection. Thus, the VAS results are relative to the VAS marked before the initial ADSCs-containing SVF injections.
The relative mean VAS of 96 joints at the end of one month follow-up was 6.55 ± 0.32, and at the end of three months follow-up was 4.43 ± 0.41 (Figure 1). The relative mean VAS of cartilage repair of 81 joints (74 knees and seven hips; excluding two ankles and two low backs) at the end of one month follow-up was 6.53 ± 0.63 and at the end of three months follow-up was 4.30 ± 0.74 (Figure 1). The lowest values of the relative mean VAS were in the age range group of 70 ~ 80 (Table 3). The relative mean VAS of bone regeneration (n = 15) in hips of AVN patients at end of one month follow-up was 6.64 ± 0.32 and at end of three months follow-up was 5.17 ± 0.32 (Figure 1). Two low back and ankle patients reported minimal clinical improvement and did not obtain post procedure MRIs.
(Enlarge Image)
Figure 1.
Pain measurements of patients. VAS and AVN are visual analog scale and avascular necrosis, respectively. Combined relative mean VAS scores (right three bars) are those of 96 joints (hip bone [left bars]: 15 joints; knee and hip cartilage [middle bars]: 81 joints). Error bars indicate standard errors. * = p < 0.05.
The complications of the concern can be summarized as follows: (i) pain and swelling: 37% of 100 joints treated joints reported development of pain and swelling after one day after the ADSCs/PRP injection. Pain swelling improved with cold compressions and routine oral NSAIDs prescriptions given on the first day of discharge. These complications were detected only in the knee joints treated. Among these patients, 51% were older than 50; (ii) infection: 0%; (iii) neurologic: 1% (a hemorrhagic stroke approximately two weeks after the procedure); (iv) tumor: 0%: (v) tendonitis/tenosynovitis: 22%. Among these patients, 68% were older than 60 and started to occur after 6 ~ 8 weeks of the procedure; and (vi) skin: 1% (a localized rash around the injection site after 1 ~ 2 days of the procedure) (Table 4).
Results
Patient Demographics and Areas Treated
From November 18, 2009 until December 17, 2010, a total of 100 joints were treated in 91 patients. As of October 2012, the mean follow-up time for all patients was 26.62 ± 0.32 months. 100 procedure follow-up contacts occurred at 12 months or more, 78 contacts at 24 months or more, and 17 contacts at 30 months (Table 1). The first patient was treated on November 18, 2009. Thus, the follow-up time for patients who were treated in 2009 and early 2010 was close to three years.
There were a total of four patients in 2009. They were all female and their age was 61, 57, 71, and 77, respectively. Of these four, the first patient received two injections of ADSCs into the knee: the first dose was injected on November 18, 2009, and the second dose was injected on April 28, 2010. The first dose of the first patient did not include PRP. Thus, the procedure was repeated on April 28, 2010 with PRP and ADSCs. Of the total of 91 patients, three patients received two treatments of identical joints and six patients received two treatments at different joints. Nine patients underwent two procedures. Of the nine, three patients received ADSCs on the same knee joints and the other six patients received ADSCs on the other knees. The second procedure of all nine patients occurred with 3 ~ 4 months after the first. Of these nine patients, only one patient did not obtain MRI after the first and second doses of ADSCs. All other eight patients obtained MRI after three months from each first and second ADSCs/PRP treatment. Thus, the total number of joints treated (n = 100) is higher than the number of patients (n = 91) treated. The mean age was 51.23 ± 1.50, with the range being 18–78 years; 45 patients were male and 46 female. The age of patients was relatively evenly distributed (Table 1). Nine patients underwent more than one procedure. In all, the patients underwent 74 knee procedures (distributed with 67.6% in the age range of 40 ~ 69), 22 hip procedures (distributed with 81.8% in the age range of 18 ~ 49), two low back procedures, and two ankle procedures (Table 2). Of the 22 hip procedures, 15 were avascular necrosis and seven were hip osteoarthritis. All 74 knees and two ankles had diagnosis of osteoarthritis while the two low back procedures had spinal disc herniation.
Pre-procedure MRIs were carried out on 86 patients. Among these, 27 patients also underwent post-procedure MRIs. Due to financial reasons, 59 patients refused to undergo post-procedure MRIs. Mean time for last MRI follow-up since the procedure was 3.11 ± 0.12 months. MRIs (as read by both examiners and physicians) were negative for any evidence of tumor formation at the implantation site.
Pain Measurements
To assess the symptom improvement of the treatment, VAS was analyzed. For all patients, VAS was marked at 10 before treatments. The patients were followed up consequently with VAS at one month and at three months after the initial injection. Thus, the VAS results are relative to the VAS marked before the initial ADSCs-containing SVF injections.
The relative mean VAS of 96 joints at the end of one month follow-up was 6.55 ± 0.32, and at the end of three months follow-up was 4.43 ± 0.41 (Figure 1). The relative mean VAS of cartilage repair of 81 joints (74 knees and seven hips; excluding two ankles and two low backs) at the end of one month follow-up was 6.53 ± 0.63 and at the end of three months follow-up was 4.30 ± 0.74 (Figure 1). The lowest values of the relative mean VAS were in the age range group of 70 ~ 80 (Table 3). The relative mean VAS of bone regeneration (n = 15) in hips of AVN patients at end of one month follow-up was 6.64 ± 0.32 and at end of three months follow-up was 5.17 ± 0.32 (Figure 1). Two low back and ankle patients reported minimal clinical improvement and did not obtain post procedure MRIs.
(Enlarge Image)
Figure 1.
Pain measurements of patients. VAS and AVN are visual analog scale and avascular necrosis, respectively. Combined relative mean VAS scores (right three bars) are those of 96 joints (hip bone [left bars]: 15 joints; knee and hip cartilage [middle bars]: 81 joints). Error bars indicate standard errors. * = p < 0.05.
Complications Reporting
The complications of the concern can be summarized as follows: (i) pain and swelling: 37% of 100 joints treated joints reported development of pain and swelling after one day after the ADSCs/PRP injection. Pain swelling improved with cold compressions and routine oral NSAIDs prescriptions given on the first day of discharge. These complications were detected only in the knee joints treated. Among these patients, 51% were older than 50; (ii) infection: 0%; (iii) neurologic: 1% (a hemorrhagic stroke approximately two weeks after the procedure); (iv) tumor: 0%: (v) tendonitis/tenosynovitis: 22%. Among these patients, 68% were older than 60 and started to occur after 6 ~ 8 weeks of the procedure; and (vi) skin: 1% (a localized rash around the injection site after 1 ~ 2 days of the procedure) (Table 4).
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