Bijan Nejadnik, MD

“I want to thank all the doctors that helped with this study and also tell clinicians to stay tuned. This is moving forward. Our hope is to one day see that a lot of patients are helped to be able to move their upper and lower extremities; that they're able to walk better, eat better, have a better quality of life. I think this is helpful not only for the patients themselves, but also for their family and people around them.”

Allogeneic modified bone marrow-derived mesenchymal stromal/stem cell (MSC) implantation, dubbed SB623 by developer SanBio, was recently investigated in the 1-year, double-blind, randomized, surgical sham-controlled, phase 2 STEMTRA trial (NCT02416492). Data suggest that the treatment is 

 in treating individuals with traumatic brain injury (TBI).

Researchers found that 39.1% of patients treated with SB623 reached a clinically meaningful improvement of greater than or equal to 10 points on the Fugl-Meyer Motor Scale (FMSS) as compared to 6.7% of controls (P = .039). The least squares (LS) mean difference between SB623 and control was 6.0 (95% CI, 0.3-1.8; P = .04; LS mean improvement, 2.3; SE, 2.5).

 reached out to Bijan Nejadnik, MD, chief medical officer, SanBio, to learn about studies planned to investigate SB623. Nejadnik also took the time to thank all the doctors involved in investigating the agent.

Kawabori M, Weintraub AH, Imai H, et al. Cell therapy for chronic TBI: Interim analysis of the randomized controlled STEMTRA trial. 

 Published online January 4, 2021. doi: 10.1212/WNL.0000000000011450

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The chief medical officer at SanBio discussed how the investigational agent SB623 is being studied in TBI and stroke, with future planned studies in Alzheimer disease. 

Stem Cell Therapy Studies in TBI and Stroke: Bijan Nejadnik, MD

"SB623, at this point in our clinical trials, has achieved improvement in the patient's function and improvement in motor impairment. Therefore, we think that the treatment will biologically change the brain parenchyma brain cells in order to improve the patient's functioning in a much more drastic and fundamental way than what they can achieve with just rehab.”

 (NCT02416492), a 1-year, double-blind, randomized, surgical sham-controlled, phase 2 trial, suggest that implantation of allogeneic modified bone marrow-derived mesenchymal stromal/stem cells (MSCs) developed by SanBio, dubbed SB623, is well-tolerated and efficacious in treating individuals with traumatic brain injury (TBI).

Researchers found that patients treated with SB623 improved by a least squares (LS) mean of 8.3 (standard error [SE], 1.4) at 6 months from baseline on the Fugl-Meyer Motor Scale (FMSS) score. The LS mean difference was 6.0 (95% CI, 0.3–1.8; 

 = .04) between SB623 and control (LS mean improvement, 2.3; SE, 2.5). In the SB623 group, 39.1% reached a clinically meaningful improvement of ≥10 points on FMSS compared to 6.7% of controls (

 reached out to Bijan Nejadnik, MD, chief medical officer, SanBio, to learn more about SB623 and its potential to restore function in TBI. Nejadnik discussed how SB623 could fill the void of disease-modifying therapies for TBI.

The chief medical officer at SanBio discussed how the investigational agent SB623 can fill the void of disease-modifying therapies for TBI.  

Bijan Nejadnik, MD

Articles

Stem Cell Therapy Studies in TBI and Stroke: Bijan Nejadnik, MD

Restoring Function in TBI with Stem Cell Therapy: Bijan Nejadnik, MD