Rheumatoid Arthritis with Stem Cell Therapy
Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients
A study done by Mashhad University of Medical Sciences, this research evaluates the effects of autologous bone marrow derived mesenchymal stem cell therapy on cellular and humoral immune responses for patients suffering from rheumatoid arthritis. The stem cells were obtained through bone marrow aspiration and cultured to then be transfused to the patients intravenously. This study has requirements, as do most others, for patients in order to be qualified for treatment; the patients must have a resistance to regular disease-modifying anti-rheumatic drugs. The patients eligible also had to be female for this particular study.
The researchers describe their main outcome measure goal as evaluating the biological responses and the “effect of chemokines in homing of immune cells” following the treatment. After extracting and cultivating the autologous mesenchymal stem cells (MSC’s), the patients receive a single dose of 1.0×10^6 to 2.0×10^6 MSC/kg intravenously. The patients also received a single dose of hydrocortisone (100ml) and oral dimenhydrinate (10ml) to prevent anaphylactic reactions. The biological effects on the cells were studied one, six, and twelve months after treatment.
The conclusion came out that the treatment was generally well tolerated, with no evidence of any major side effects being seen. The researchers concluded that the experiment “justify further investigation of this innovative therapy in patients with RA”.
Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis (RA)
Conducted by Kang Stem Biotech Co., Ltd., this study looks into the safety of using FURESTEM-RA Inj. (allogenic human umbilical cord derived mesenchymal stem cells) on patients with moderate to severe rheumatoid arthritis. The study claims that although DMARDs (disease-modifying anti-rheumatic drugs) are effective, they lack efficacy in some patients and can even cause serious complications for other patients.
The researchers will inject 2.5×10^7 stem cells into patients and immediately follow with DMARDs to see how the two treatments work together. The experiment will examine if any adverse events occurred after treatment such as a physical examination, lab tests, ECG, and vital signs.
No serious adverse effects were recorded during or after the infusion. A significant increase of regulatory T-cells of the peripheral blood was observed as well as remission of the disease. The therapeutic effects maintained for 3-6 months without continuous administration. This concludes that the treatment of UC-MSC’s plus DMARDs may provide a safe, and persistent benefit for patients with RA.
Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis
Another study done by the Royal Institute to evaluate the therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells in patients with knee osteoarthritis caused by rheumatoid arthritis. The experiment is a parallel assignment of the patients split into two groups; one group (Group A) receiving only routine medical therapies and a placebo injected into the knees and the other group (Group B) receiving MSC’s in addition to routine medical therapy. The outcomes were measured in a period of one, three, six, and twelve months after treatment to examine WOMAC scores, DAS28 scores, radiography assessments, and biochemical analysis with lab tests.
The placebo group received a normal salon injection while the experimental group received an intra-articular knee implantation of 40 million autologous bone marrow-derived MSC’s per joint. Pain, physical improvement, an evaluation of walking, and an examination of the articular cartilage were then recorded for up to a year.
The results came out that there were no adverse effects on the patients after treatment or follow-ups. The WOMAC and VAS scores and reported superior findings in the patients who received treatment, however it was not sustained after twelve months. The researchers concluded that the MSC’s injection appears to be safe and well tolerated. They claimed to also notice a trend in clinical efficacy, which in turn, justify the need for further investigations over an extended period with larger numbers of RA patients.
Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis Patients
This last completed study was conducted by Tigenix S.A.U. as a single blind, fixed dose escalation clinical trial, with three treatment groups designed to access the safety, feasibility, and tolerance of using expanded allogenic adipose-derived mesenchymal stem cells to patients with RA. This study also aims to identify if there’s any possible dose limiting toxicity as well as obtain information on the clinical and functional effects of the intravenous infusion to explore pharmacodynamics parameters.
The patients were randomized into different groups and each given a different level of dosage of the eASCs or placebo: the first group receives 1 million cells/kg administered one, eight, and fifteen days; the second group receives 2 million cells/kg administered one, eight, and fifteen days; and the third group receives 4 million cells/kg administered one, eight, and fifteen days. The placebo group receives a placebo of Lactate Ringer’s solution given on the same days as the treatment starting at 20ml, then 40ml, and lastly 80ml.
This study states that a total of 141 adverse events occurred following treatment from every group with the most serious being lacunar infarction from a patient or patients in the first group. The researchers concluded that the treatment was generally well tolerated, with no evidence of dose-related toxicity. These data indicate that further investigation into using eASCs is imperative to perfecting treatment.
Studies Not Yet Recruiting
Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis
A clinical trial conducted by Celltex Therapeutics Corporation that is a combined Phase 1 dose escalation study and Phase 2a randomized, placebo controlled and double blinded study that looks into using intravenous injections of autologous adipose stem cells for RA patients. The researchers main objective is to monitor the safety and evaluate the efficacy for up to 52 weeks.
The first group of subjects will receive a single dose escalation of autologous AdMSC’s by intravenous infusion. The second group will receive three doses of 2.0-2.86×10^6 cells/kg on days one, four, and seven through intravenous infusion. The last group will receive three doses of placebo on the same days via intravenous infusion. The autologous adipose-derived MSC’s will be from the patients own abdominal fat tissue that will then be cultured and expanded before the infusions take place.
Following treatment, the researchers will evaluate any adverse effects, related or not with AdMSCs, to determine the safety and tolerability. They will also look for any signs of degeneration or regeneration in the target areas of the patients.
A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis
Hope Biosciences is investigating how autologous adipose-derived mesenchymal stem cells can potentially help treat for rheumatoid arthritis patients by evaluating the safety of treatment through a single IV infusion. The study will be a phase 1/2a, open label, single-dose investigation with the primary objective to measure the number and frequency of adverse effects on the patients. The researchers will also study the ability of the MSC’s to alter RA-related inflammation by measuring the biological state of the patients after treatment for up to twelve months.
The patients will receive a single dose of autologous adipose-derived mesenchymal stem cells with follow-ups and joint assessments being administered one, three, six, and twelve months after treatment. The outcome measures include evaluating safety, tolerability, and comparing all the biological factors such as studying Tumor Necrosis factor levels, interleukin levels, C-reactive protein levels, erithrosedimentation rates, and Joint Count levels.