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Leading Mesenchymal Stem Cell Clinical Trials
Stem cell trials take a long time between initiation and completion, sometimes even longer than a decade. Currently over 50 clinical trials using mesenchymal stem cells are under progress, and we have showcased below some of the leading clinical trials which are in advanced stages of human clinical trials:
Treatment of Heart Attack
In 2009, Osiris completed a Phase 1 double-blind, placebo-controlled study in 53 patients that demonstrated the safety of Prochymal* in cardiac patients suffering from their first heart attack. Additionally, treatment with Prochymal* significantly improved cardiac function, patient global assessment and reduced cardiac arrhythmias (irregular heartbeat) when compared to placebo. In March 2011, they reported the completion of enrollment of a total of 220 patients into a double-blind, placebo-controlled trial from 33 leading clinical centers in the United States and Canada.
Osiris Therapeutics has received orphan drug designation for Prochymal* as a treatment for type 1 diabetes mellitus from the FDA. Reportedly, a Phase II trial is evaluating the safety and efficacy of Prochymal* in preserving insulin production in patients 12 to 35 years old recently diagnosed with type 1 diabetes. The 62 patient, double-blind, placebo-controlled trial is being conducted at 20 medical centers across the US.
Graft vs Host Disease
Data presented at the 2010 BMT Tandem Meeting showed that Prochymal achieved an overall response rate of 63% when used as a rescue therapy in children suffering from severe treatment resistant graft vs. host disease (GvHD). Furthermore, the study demonstrates that response to Prochymal significantly improved survival.
Congestive Heart Failure
In December 2010 a scheduled interim analysis of safety and of time-dependent hard efficacy endpoints was performed on the 45 patients who received Revascor# or placebo and had been followed for a mean of atleast months 18 months/patient. According to the phase 2 trial results, patients who received a single injection of Revascor have had less cardiac events, deaths and hospitalizations during the follow-up period to date than control patients.
Mesoblast has completed a pilot clinical trial for non-healing, long bone fractures in the legs. The successful results showed that bony union and healing was achieved within a median time of approximately four months after stem cell implantation, compared with what otherwise would have been permanent non-healing of the fractures in the absence of cell therapy. The Australian Therapeutic Goods Administration (TGA) has issued a licence to Mesoblast to commercially manufacture and distribute patient specific or autologous mesenchymal stem cell products to hospitals and clinicians across Australia.
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Mesoblast is now approved to begin randomized, placebo-controlled, double-blind Phase II clinical trials for its mesenchymal stem cell product, "RepliCart", in the treatment of osteoarthritis of the knee in patients who have undergone reconstruction of a ruptured anterior cruciate ligament (ACL) within 6 months of a traumatic knee injury. The clinical trials will enroll 24 patients between the ages of 18 and 40 who will either be administered RepliCart in combination with hyaluronan, or just hyaluronan alone. Preclinical trials were successful in demonstrating the ability of a single injection of the allogeneic stem cells contained in RepliCart to regenerate joint cartilage and prevent osteoarthritis in animal models.
Next : Research
Dr Kamini A Rao - Past President,
FOGSI Gynecologist, Bangalore
" The process of collecting the menstrual blood stem....."
Its a Kutung!
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