Autologous Hematopoietic Stem Cell Transplantation for Refractory Lupus Nephritis

A completed study done by Nanjing University School of Medicine that looks into the efficacy, remission, survival, and safety of administering hematopoieitic stem cells to patients diagnosed with refractory Lupus Nephritis. It is a single group assignment including only patients who had no response to at least one kind of preliminary treatment, or having persistently positive antibodies.

Peripheral blood stem cells were mobilized and harvested. The patients received certain drugs and therapies before and after the stem cell reinfusion took place to prepare the immune systems.

The primary focus of the experiment was to measure the renal remission rate; however, renal survival and treatment related mortality were also measured. The results of this experiment have not been posted.

https://clinicaltrials.gov/ct2/show/NCT03828071?id=NCT00076752+OR+NCT00750971+OR+NCT03828071+OR+NCT03580291+OR+NCT00278538+OR+NCT04184258+OR+NCT03171194+OR+NCT02633163&draw=2&rank=2&load=cart

 

 

Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST)

A currently recruiting study sponsored by Charite University that claims that “current therapies are insufficient to control [systemic Lupus Erythematosus]…, and their clinical prognosis remains poor due to the development of vital organ failure, cumulative drug toxicity and to the increased risk of cardiovascular disease and malignancy.”  The researchers’ goal for this trial is to test how immunoablative chemotherapy followed by autologous hematopoietic stem cells can eliminate auto reactive T and B lymphocytes and give regeneration to the immune system.

This is a non-randomized, parallel assignment where immunoablation and autologous hematopoietic stem cells are compared against the best currently available immunosuppressive therapy. Afterwards, the serologic response, immune reconstitution, and organ-specific response parameter will be measured for results.

https://clinicaltrials.gov/ct2/show/NCT00750971?id=NCT00076752+OR+NCT00750971+OR+NCT03580291+OR+NCT00278538+OR+NCT04184258+OR+NCT03171194+OR+NCT02633163&draw=2&rank=5&load=cart

 

 

Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus

A completed study with results conducted by Northwestern University to test if chemotherapy with immunosuppressive drugs followed by hematopoietic stem cell transplantation will result in the improvement in lupus among patients. Labs for blood count, chemistry panel, and liver function tests will be accessed after the treatment is administered.

This is a single group clinical trial with the primary outcome measure to see the survival rate of patients undergoing this treatment. It is measured six months, yearly, then every five years.

The results posted that five out of thirty patients had serious adverse effects after the stem cell transplantation. Other adverse effects happened as well to patients after treatment. Four of the patients underwent only chemotherapy, and showed no remission after treatment. The rest of the patients underwent chemotherapy, immunosuppressive drugs, and stem cell transplantation, and showed remission for up to five years.

It can be concluded that more research needs to be done to perfect this experiment. Due to the number of adverse effects, one or more parts of the trial need to be decreased or removed. Through more testing, this is a plausible treatment for systemic lupus erythematous.

https://clinicaltrials.gov/ct2/show/results/NCT00278538?id=NCT00076752+OR+NCT00750971+OR+NCT03580291+OR+NCT00278538+OR+NCT04184258+OR+NCT03171194+OR+NCT02633163&draw=2&rank=6&view=results&load=cart

 

 

Human Umbilical Cord Mesenchymal Stem Cells Treatment for Lupus Nephritis (LN)

A study that is not yet recruiting by Lingyun Sun; they claim that in testing mesenchymal stem cells on animal models, the results came out confirmed for efficacy and safety. Their goal for this study is to evaluate how MSC’s work compared to immunosuppressive drugs (mycophenolate mofetil) for patients battling lupus nephritis (LN).

The trial describes a previous trial done by investigators where (LN) patients were treated with allogenic MSC’s. “The outcomes revealed that the total response rate was 60%, the mortality rate of 2 to 5 years decreased from 35%-45% to 6%.” This proves there is a great outlook on using this from of treatment as a primary form of care for lupus nephritis.

For this specific trial, it will be a randomized parallel assignment with one group receiving pulse infusion of MSC’s with a placebo drug, the other group will receive immunosuppressive drugs along with placebo of MSC’s. The primary outcome measure is to assess the total remission rate. Other outcome measures are to assess many different biological levels.

https://clinicaltrials.gov/ct2/show/NCT03580291?id=NCT00076752+OR+NCT03580291+OR+NCT04184258+OR+NCT03171194+OR+NCT02633163&draw=2&rank=2&load=cart