In the study group, significant improvements were achieved in functional status (ODI), pain relief (NRS-11), and other parameters (EQ-5D-3L, GMH, GPH) compared to the control group. At the 12-month follow-up, 67% of patients in the study group achieved MCID utilizing ODI compared to 8% in the control group. Pain reduction of greater than 2 points was seen in 74% of patients at 3 months, 66% at 6 months, and 56% at 12 months, with both MCID and pain relief significantly different compared to the control group. Opioid use decreased in the study group but increased slightly in the control group.
We observed no procedure or stem cell-related adverse events or serious adverse events during the 1-year follow-up period. VAS, ODI, and SF-36 scores significantly improved in both groups receiving both low (cases 2, 4, and 5) and high (cases 7, 8, and 9) cell doses, and did not differ significantly between the two groups. Among six patients who achieved significant improvement in VAS, ODI, and SF-36, three patients (cases 4, 8, and 9) were determined to have increased water content based on an increased apparent diffusion coefficient on diffusion MRI.
The study showed a reduction in pain and improvement in function after nonsurgical treatment with autologous BMC. Patients receiving greater than 2,000 CFU-F/ml had a faster and greater reduction in pain. Patients older than 40 years who received fewer than 2,000 CFU-F/ml had a lower pain reduction compared to all other patients.
MPC treatment showed significant improvement in VAS and ODI compared to the control group at various time points through 36 months, according to various analyses, including the proportion of subjects achieving the minimally important change and clinically significant change composite endpoints.