Biologic Augmentation with Mesenchymal Stem Cells in Patients Undergoing Anterior Cruciate Ligament Reconstruction

This study will evaluate the efficiency of biologic augmentation of ACL reconstruction with bone marrow derived mesenchymal stem cells as measured by magnetic resonance imaging (MRI) to detect graft healing and integration. Secondary endpoints will include validated patient reported outcome measures, as well as functional outcome using objective examination findings. The hypothesis of this study is that there will be improved graft healing and integration at three to nine months as measured by decreased signal intensity and heterogeneity on T2* MRI following administration of BMAC during ACL reconstruction compared to the control group. Additionally, patient reported outcomes and physical examination findings will be improved at an earlier time in those with BMAC to their allograft compared to the control. This study will be a prospective randomized trial of patients undergoing arthroscopic reconstruction of full thickness ACL tears. This study will include 32 patients, 16 in each group. Follow-up will take place at 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months.

The first group will receive the Mesenchymal Stem Cells. This includes 1-4 mL of bone marrow aspirate concentrate (BMAC) containing mesenchymal stem cells (MSCs). A small incision will be made on the anterior superior iliac spine to withdraw aspirate. The BMAC will be injected into the ACL allograft prior to implanting into the patient.

The second group received the control sham incision, where it will also be injected on the anterior superior iliac spine.


Regenexx SD Versus Exercise Therapy for ACL Tears

This study shows a randomized controlled trial of Regenexx SD versus exercise therapy for treatment of partial and complete, non-retracted anterior cruciate ligament tears. The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx SD vs. Exercise Therapy treatment of partial and complete, non-retracted knee ACL ligament tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months. Secondary objectives include evaluation of MRI evidence of tendon repair; incidence of postoperative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

This study will be a prospective, randomized, controlled to include 25 subjects treated with Regenexx SD and 25 subjects treated with exercise therapy alone with the exercise group crossing over to the injection group at 3 months. Subjects will have a partial or complete, non-retracted ACL ligament tear as evidence with MRI. Subject will be enrolled within 60 days prior to Regenexx-SD injection or initiation of exercise therapy and take part in follow-up visits for two years following treatment. Follow up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection. The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint. Subjects will continue to be followed through the 2 year endpoint with data analysis performed at the 1 year and 2 year time points.


Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee

            Researchers at OhioHealth created a study to evaluate how autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections will react in respect to pain, function, and quality of life for up to a year for patients with knee osteoarthritis. The study is compared to a control group receiving a Gel-One® hyaluronate injection. The study is a parallel assignment of about 30 randomized participants who are in phase 2 of knee osteoarthritis (KOA).

            In the experimental group, 60mL of bone marrow is taken from a bone near the hip and about 6mL of BMAC is injected into the knee joint, which is directly followed by an injection of PRP. The platelet-rich plasma is taken from either arm at about 60mL of the venous blood. Approximately 5mL of PRP is injected directly after the BMAC. The control group  was given a single injection of Gel-One® into the target knee

            The patients had a 3 month, 6 month, and 12 month follow-up to access pain, symptoms, function in ADL, function in sports and recreation, and knee-related quality of life using the Knee injury and Osteoarthritis Outcome Score (KOOS). They also measured mental and physical health using the Patient Outcomes Measurement Information System (PROMIS®) Lastly the numeric pain rating scale was used as well.

            The final outcome produced very positive results. In all three assessment measures the scores went up for the first few months then remained the stay stagnant for the rest of the time of the trial for both groups. There were also no reported adverse effects of the treatment, showing that all participants responded well with the treatment. This proves that the treatment used is a valid option in slowing the progression of arthritis.  gives the complete study details for this clinical trial.


Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis

            This study done by the Royan Institute aim to evaluate the therapeutic effects of intra-articular injection of bone marrow mesenchymel stem cells (BM-MSCs) in 60 patients with knee osteoarthritis in order to find a better alternative for rheumatoid arthritis compared to traditional treatment (pain management and/or knee replacement surgery). This study deals in cases where participants are in either phase 2 or phase 3 of rheumatoid arthritis. The study will divide participants randomly into two groups: a control group who will be receiving a placebo of a normal saline solution injected into the knees and routine medical therapies, and the experimental group which receives MSCs in addition to routine medical therapy. The researchers would then access the outcomes of the experimental group using WOMAC questioners, DAS28 scoring, radiographies assessments, and biochemical analysis.

            The results of this study reported superior findings where the experimental group had no adverse effects to the treatment, and improvement in all measurement tests. However, the researchers concluded that this improvement could not be significantly sustained beyond 12 months. There is also a reported trend toward clinical efficacy. “These results, in our opinion, have justified the need for further investigations over an extended assessment period with larger numbers of RA patients who have knee involvement.”

   Gives the full text for this clinical trial as well as images of the research.


Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis

            A study done by R-Bio which examines how Adipose Tissue derived Mesenchymal stem cells (MSCs) can effect patients with degenerative arthritis by alleviating the progression of the affected cartilage in the bone. The clinical trial works with patients in two phases: one group received the treatment first with groups of three patients where each group is given either a low, high, or medium dosage. The second phase is consisted of nine patients all receiving a high dosage. The MSCs are first isolated from adipose tissue and cultured, then administered into the cartilage tissue lesion through orthopedic surgery. The primary outcome of the study is to evaluate the safety of the treatment as well as each patients pain scores through WOMAC (Western Ontario and McMaster Universities Arthritis Index). They also aim to evaluate the histology and physical activity of each patient.

            Towards the end of the study the researchers found that the treatment did not leave any adverse events, and the WOMAC score improved six months after surgery. The size of the cartilage defect decreased while the volume of cartilage increased in the medial femoral and tibial condyles in the high dose group. Arthroscopy showed that the size of the cartilage defect decreased in the medial femoral and medial tibial condyles of the high dose group as well. These results show that mesenchymal stem cells improved overall function and pain of the knee without causing adverse events, and reduced cartilage defects by regeneration of hyaline- like articular cartilage.

             The participants of the study were examined two years later to follow up on the pain and knee function. Patients in the low and medium dose groups reported deterioration after a year of treatment, where patients in the high dosage group reported deterioration after 2 years following treatment. This encourages a larger randomized clinical trial to be done; however, this study showed potential concerns about the durability of the outcomes, suggesting the need for further studies. for more information on this trial.


Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo)

            This clinical trial was done at University of Valladolid in Spain to evaluate using bone marrow allogenic mesenchymal stem cells as treatment for knee osteoarthritis. This is a follow-up trial to their previous results with autologous MSCs. This clinical trial comprises of two groups: the experimental group who will be receiving intra-articular transplantation of allogenic MSCs, and the control group who will be receiving intra-articular injection of hyaluronic acid. The researchers will evaluate pain, disability, quality of life, and quantitive changes of the cartilage for the course of a year.

            The MSCs are prepared from bone marrow of healthy donors and expanded for 3-4 weeks. Then an intra-articular injection of 40 million MSCs are administered to the experimental group. The control group receives a single 3mL injection of 60 mg of hyaluronic acid. The researchers will investigate any adverse events as well as pain and evolution of the cartilage.

            Over the course of a year the researchers confirmed the efficacy and safety of treatment. The experimental group displayed improvement in “algofunctional indices” compared to the control group. There was a significant decrease in areas with poor cartilage, improving the overall quality of the area. The researchers compared this trial to their first one in which autologous MSCs were used surgically and they concluded that allogenic MSCs are a valid alternative for the treatment of chronic knee osteoarthritis since it does not require surgery, provides pain relief, and significantly improves the cartilage quality.



Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

            This study was conducted by the Royan Institute to access using bone marrow mesenchymal stem cells (BM-MSCs) in patients with hip osteoarthritis. The study took participants who were candidates of total hip replacement who will instead be receiving an intra-articular injection of cultured autologous BM-MSCs. All participants will also undergo bone marrow aspiration in order to extract and culture the autologous BM-MSCs. Evaluation of the patients will be done before and six months after treatment to access pain relief and functional improvement of the joints being examined.

            The researchers aim to evaluate several outcome measures such as hip joint swelling, deterioration of the joint, any allergic reactions, and respiratory reactions. They also will evaluate pain, physical function, and thickness of the cartilage in the area two months preceding the treatment. More follow-up exams continued 6, 12, and 30 months post-transplantation.

            There were no severe adverse effects from the transplantation recorded from any of the patients during the trial. All biological functions remained normal such as liver function, hematology, and biochemistry. All patients displayed benefits of the treatment such as increased walking and improved WOMAC scores. This study proves how mesenchymal stem cells are effective and safe for osteoarthritis is safe in many affected areas of the body. The researchers of this experiment conclude that further studies should be done with larger sample sizes and longer follow-up periods to confirm the findings. provides the full text of this study as well as graphs and charts of improvement.



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