Micro-liposuction treatment for alopecia completes stage II clinical trial in the US
Cytori Therapeutics has announced that its Kerastem Technologies brand has completed a stage II trial investigating male and female pattern hair loss.
Cytori Cell Therapy was used in a randomised, blinded and controlled study that included 70 patients in the US with early stage male and female pattern baldness.
This form of hair loss, known as Androgenic Alopecia is the most common form of alopecia in the US.
The therapy involves collecting tissue from elsewhere in the body and processing it to obtain stem cells from fat, purified fat and enriched fat. This is then and injected into affected areas on the scalp.
Subjects taking part in the study were given one of four treatments over a period of six months. The patients will be monitored for a total 12 months.
Treatments included micro-liposuction followed by subcutaneous scalp injections of purified adipose, prepared with the Puregraft System and 1,000,000 ADRC prepared with the Celution System per square centimetre of scalp.
Other patients were given the same treatment with 500,000 ADRC prepared with the Celution Systen per square centimetre of scalp.
As a control, other sets of patients were treated with micro-liposuction and subcutaneous scalp injections of purified adipose, prepared with the Puregraft System alone and others were given subcutaneous injections of saline.
Dr Marc H. Hedrick, President and CEO at Cytori, explained: “Early proof of concept clinical data has shown promise and Kerastem expects a read our from the trial in approximately one year. This therapy, if approved, could create a significant value for our stockholders.”
Brad Conlan, CEO at Kerastem, added: “Successfully completing enrolment of [the trial] is a foundational step towards Kerastem’s goal to be the first US FDA approved stem and regenerative cell therapy to treat hair loss.”
The trial is based on previous clinical work undertaken in Japan, where Kerastem therapy is already offered at several clinics.
Cytoria Therapeutics is developing autologous cell therapies from adipose tissue to treat several medical conditions. Previous trials and studies have suggested that the therapy can improve blood flow.
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