Research
Our research team conducts high-quality clinical research published in good PubMed-indexed journals. Some of our recent studies are listed below.
Publications:
Review of the Published Literature Confirms the Safety of Intravenous Infusion of Mesenchymal Stem Cells
Amir Barmada, Joshua Sharan, Nicolas Band, Tobias Rumschlag, Arwah Yaqub, Eliana Liebman, Chadwick Prodromos
Abstract: Background: Mesenchymal stem cells (MSCs) have been shown to decrease inflammation and enhance healing due to their immunomodulatory properties and secretion of growth factors. Intravenous infusion is the most common delivery route of MSCs, and it is used for the treatment of a wide variety of conditions, with established efficacy...
Click here for more information.
Serious Adverse Events Have Not Been Reported with Spinal Intrathecal Injection of Mesenchymal Stem Cells: A Systematic Review
Amir Barmada, Joshua Sharan, Nicolas Band, and Chadwick Prodromos
Abstract: Background: Mesenchymal stem cells (MSCs) are partially differentiated multipotent cells. They can be derived from various tissues such as the umbilical cord, bone marrow, and adipose tissue. Intrathecal administration of MSCs has shown efficacy for various neurological conditions including multiple sclerosis, autism, traumatic brain injury, and many more...
Click here for more information.
Autologous Mesenchymal Stem Cell Treatment is Consistently Effective for the Treatment of Knee Osteoarthritis: The Results of a Systematic Review of Treatment and Comparison to a Placebo Group
Chadwick Prodromos, Susan Finkle, Tobias Rumschlag, and John Lotus
Abstract: Background: Numerous studies have used autologous mesenchymal stem cell injections (AMSCI) to treat osteoarthritis. We hypothesized that AMSCI is an effective osteoarthritis treatment with increasing effective at higher doses. Methods: We conducted a PubMed search for human clinical studies using AMSCI for the treatment of osteoarthritis (OA) and a second search for placebo arms of injectate OA treatment. Inclusion criteria included treatment outcomes ratings both pre-treatment and at least 6 months post-treatment...
Click here for more information.
Administration of Autologous Mesenchymal Cells for the Treatment of Arthritis
Chadwick Prodromos and Tobias Rumschlag
Abstract: Background: Injection of autologous mesenchymal stem cells (AMSCs) as stromal vascular fraction, culture expanded adipose derived stem cells, minimally manipulated fat graft, bone marrow aspirate or cultured bone marrow MSCs, for osteo- and inflammatory arthritis have shown good clinical efficacy in many studies. Questions have been raised as to their safety despite no evidence known to us that they are unsafe when used this way. We hypothesized that AMSC injections are completely safe for the treatment of arthritis...
Click here for more information.
First Human Report of Relief of Lumbar and Cervical Discogenic and Arthritic Back Pain after Epidural and Facet Joint Mesenchymal Stem Cell Injection: A Case Report
Chadwick C. Prodromos, Joshua Sharan, Amir Barmada
Abstract: Introduction: Lumbar back pain is a multifactorial condition that is frequently caused by discogenic disease or facet joint disease, which has frequently been shown to occur concomitantly. Due to the immunomodulatory and anti-inflammatory properties of mesenchymal stem cells (MSCs), we hypothesized that they would be efficacious in the treatment of spinal arthritis. Multiple studies have demonstrated that intradiscal injections of MSCs can be efficacious, however; this has not been without risk as multiple studies have described adverse events including discitis, osteomyelitis, epidural abscess, cauda equina syndrome, and inducing disc herniation. Therefore, we believe that treating simultaneous discogenic and facet joint disease can be done by directly injecting the facet joint along with epidural injection, which would saturate the disc with beneficial cytokines and immunomodulatory...
Click here for more information.
Autologous Biologic Treatment with Fat, Bone Marrow Aspirate and Platelet Rich Plasma Is an Effective Alternative to Total Knee Arthroplasty for Patients with Moderate Knee Arthrosis
Chadwick Prodromos and Susan Finkle
Abstract: Background: Osteoarthrosis (OA) of the knee affects millions worldwide. Total Knee Arthroplasty (TKA) is common but associated with substantial cost and morbidity. Prior studies of intra-articular injection of fat, bone marrow aspirate (BMA), and platelet rich plasma (PRP) have shown clinical benefit. We hypothesized that injection of autologous adipose tissue, BMA, and PRP would provide significant benefit for patients with moderate knee OA resulting in avoidance of total knee arthroplasty (TKA) in most, with discontinuance of NSAIDs and other drugs...
Click here for more information.
Treatment of Rotator Cuff Tears with Platelet Rich Plasma: a Prospective Study with 2-Year Follow-Up
Chadwick Prodromos, Susan Finkle, Alexandra Prodromos, Jasmine Li Chen, Aron Schwartz, and Lucas Wathen
Abstract: Background: Surgical treatment of full-thickness rotator cuff (RC) tears is associated with generally good results. There is no consensus regarding the treatment of partial thickness tears that fail activity modification and physical therapy. Corticosteroid injections are sometimes used but have been associated with tendon damage. Platelet rich plasma (PRP) however has been shown to enhance connective tissue healing. We hypothesized that dual PRP injection into the rotator cuff insertion as well as the area of the tendon proximal to the insertion would be safe and would result in good clinical outcomes without surgery, that the effects would last out to two years, and that results would be better with lesser tendon damage...
Click here for more information.
Presentations:
Human pilot experience demonstrating the long-term regenerative properties of local immunomodulation associated with autologous stem cell therapy treatments for osteoarthritis of the knee and spine.
Moviglia GA, Moviglia-B MT, Bolander J, Piccone S, Updike T, Vaughan W, Mahajan N, Santacoloma E, Grangeat A, Kozima J, Ramirez R, Prodromos C, Atala A, Poheling G
Presented at the International Cartilage Repair Society (ICRS) Annual Meeting in Barcelona, Spain September 2023. Abstract: Purpose: Demonstrate that the use of tissue-specific local immunomodulation associated with autologous stem cell implantation is necessary to regenerate tissues, control symptoms, improve joint function, and sustain its effects for more than 5 years...
Click here for more information.
The Aggregated Data from Normal Saline Placebo Arms of Hyaluronic Acid and Other Knee Injection Studies For OA Can Be Used as a Control Group for Single-Armed Knee Injection Studies
Chadwick Prodromos, John Lotus, and Susan Finkle
Presented at 2021 European Society for Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA). Abstract: Purpose: The treatment of osteoarthritis (OA) by injection avoids surgery when successful. Platelet-rich plasma (PRP) and stem cell treatments are commonly performed for this purpose. Studies of these treatments are often criticized due to lack of a control group. However, numerous studies of hyaluronic acid and other injectates report detailed characteristics of their placebo arms in which saline was injected. Any benefit seen thus represents either a placebo effect or a saline treatment effect. Here, the magnitude and duration of this placebo/saline effect is characterized so that the accumulated data can serve as a historical control group against which the effects of treatment arms of knee injection studies can be measured...
Click here for more information.
PRP Injection of the Arthritic Glenohumeral Joint is Safe, Effective, and Avoids Joint Replacement in Many Patients at 2-8 Year Follow-Up
J. Sharan, C, Prodromos, S. Finkle, A. Barmada, A. Schwartz, J. Delapaz, N. Band
Presented at the International Cartilage Repair Society (ICRS) in Berlin, Germany in June 2022. Abstract: Purpose: Platelet Rich Plasma (PRP) injection has been shown to benefit knee osteoarthritis (OA). We are unaware of any published studies evaluating efficacy for glenohumeral shoulder OA. We hypothesized that PRP would be safe, would improve glenohumeral OA, and would result in joint replacement avoidance in many patients...
Click here for more information.
PRP Injection Resulted in Joint Replacement Avoidance in 568 OA Knees at 3 - 7 Year Follow-Up, Even Bone on Bone
J. Sharan, S. Finkle, A. Barmada, N. Band, K. Ralston, K. Bruch, K. Phelan, B. Scheuler, C. Prodromos
Presented at the International Cartilage Repair Society (ICRS) in Berlin, Germany in June 2022. Abstract: Purpose: Most knee PRP studies report only short-term results and fail to assess total knee replacement (TKR) avoidance/joint survivorship as an outcome. We wished to evaluate the efficacy of PRP at 3-year follow-up with particular attention to TKR avoidance...
Click here for more information.
The Grashey True Shoulder AP X-Ray Accurately Reflects Glenohumeral Joints Space and Predicts PRP Efficacy, The Traditional AP Does Neither
A. Barmada, J. Sharan, S. Finkle, N. Band, J. Delapaz, A. Schwartz, A. Dawes, C. Prodromos
Presented at the International Cartilage Repair Society (ICRS) in Berlin, Germany in June 2022. Abstract: Purpose: To demonstrate that the shoulder AP view radiograph does not accurately reflect true glenohumeral (GH) joint space narrowing when compared to the Grashey view...
Click here for more information.
Pre-Publication Abstracts:
Mesenchymal Stem Cell Injection is Effective and Completely Safe for the Treatment of Chronic Back and Neck Pain
Chadwick Prodromos, Mark Hirmiz, Keanne Jabbarzadeh, Ethan Cui, and Kenneth Candido
Background: The treatment of recalcitrant chronic back and neck pain is a severe unsolved problem. Steroid injections are not significantly effective. Surgery is very painful, often fails, has high complication rates, and usually cannot be salvaged. Mesenchymal stem cells (MSCs) improve healing, are anti-inflammatory and extremely safe. We hypothesized that translaminar epidural and facet MSC injection with MSC IV infusion would provide effective and sustained relief of back and neck pain with complete safety.
Methods: Patients with chronic back and/or neck pain unresponsive to physical therapy were included. AlloRx (Vitro Biopharma, Golden Colorado) umbilical cord-derived MSCs were infused intravenously and injected tranlaminarly into the epidural space and painful facet joints. Some patients elected concomitant lumbar disk space injections. Patients were evaluated before and 1, 3, 6, 12, 18, and 24 months post-treatment with VAS, Quebec score, and a global improvement rating.
Results: 48 patients met the inclusion criteria, with 36 having at least 6 months of follow-up. At least 80% follow-up was obtained for all metrics at all time points. There were no serious adverse events. 67%, 74%, 61%, and 62% of patients showed clinically important pain relief at 1, 3, 6, and 12 months after one treatment. Twelve patients had concomitant disk space injection but without significantly higher rate of improvement. 85%, 82%, and 60% of 3-month responders had continued pain relief at 6, 12, and 18 months post-treatment. Nine patients had prior failed back surgery. Seven had follow-up of > 6 months with 88%, 86%, and 100% having significant pain relief at 3, 6, and 12 months after treatment. Regarding neck pain, 88%, 86%, and 75% of patients had pain relief at 3, 6, and 12 months.
Conclusions: MSC epidural/facet/IV injection produces pain relief similar to surgery. Unlike surgery, however, there are no complications, no serious side effects and only minimal transient post-treatment pain, It is also consistently effective for failed back surgery. We believe that epidural/facet/IV MSC injection is the treatment of choice for chronic back and/or neck pain unresponsive to physical therapy.
Mesenchymal Stem Cell Infusion is Consistently Effective in Improving Autism Behavioral Parameters and EEG Metrics
Chadwick Prodromos, Mark Hirmiz, Keanne Jabbarzadeh
Background: Autism Spectrum Disorder (ASD) produces troubling behavior and affected one in every thirty-six children in 2020. There is no cure and no reliable treatment. Intravenous Mesenchymal stem cell (MSC) infusion has provided efficacy in limited prior studies.
Methods: Inclusion criteria were diagnosis of ASD by an appropriate medical specialist and minimum six month follow-up after MSC treatment. Evaluation included Autism Spectrum Rating Scale (ASRS) pre and post treatment. and a global improvement assessment post treatment. Electroencephalogram (EEG) was performed pre and post treatment in three patients.
Results: Eight patients met criteria. All had significant improvement one month after treatment. Seven of the eight patients had significant improvement minimum six months post treatment by both Global Improvement and ASRS ratings. The three EEG evaluated patients all showed significant improvement post treatment. No minor or severe adverse events occurred in any patient. One patient had longstanding absence seizures which almost completely disappeared for the full two years of his latest follow-up.
Conclusions: MSC IV infusion was shown to be consistently, significantly effective reducing symptoms in a high (88%) percentage of ASD patients with results extending minimum six months post treatment, and usually much longer, with no adverse events seen.
Complete Lasting Reversal of Polycystic Ovary Syndrome from Intravenous Umbilical Cord Derived Mesenchymal Stem Cell Infusion
Chadwick Prodromos, Keanne Jabbarzadeh, Mark Hirmiz
Introduction: Polycystic ovary syndrome (PCOS) affects an estimated 8–13% of reproductive-aged women. Up to 70% of affected women remain undiagnosed worldwide. PCOS is the most common cause of anovulation, a leading cause of infertility, and can produce many troubling symptoms (1). Until now, there has been no cure for PCOS, only symptom management. Studies show that people with PCOS have long-term, low-grade inflammation in which polycystic ovaries produce androgens (male hormones) and insulin (2,3,4). This can lead to heart and blood vessel problems (5). The chronic low-grade inflammation-induced polycystic ovaries also may cause: missed periods, irregular periods, or very light periods, ovaries that are large or have many cysts, excess body hair, including the chest, stomach, and back (hirsutism), weight gain, especially around the belly (abdomen), acne or oily skin, male-pattern baldness or thinning hair, and infertility (6). We here describe a remarkable case history of a PCOS patient successfully treated with stem cells...
Click here for more information.
