ThermoGenesis ($KOOL) now in CLI ! (video)

ThermoGenesis Corp (NASDAQ: KOOL) press released an update on their Res-Q clinical evaluations:

ThermoGenesis Provides Update on Res-Q® Clinical Evaluations at Leading Stem Cell Therapy Conference

INITIAL DATA SHOW POSITIVE OUTCOMES IN TREATING CRITICAL LIMB ISCHEMIA AND LONG BONE FRACTURES

What is Res-Q ?  This is a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP). The product is being tested in India in a trial co-sponsored by ThermoGenesis and Totipotent SC, the company's distributor for the Res-Q in India.

The trial has evaluated n=10 of n=15 planned patients with advanced CLI. Safety and AFS (limb salvage) at one year are being evaluated. Secondary endpoints such as ABI (ankle brachial index), six minute walk test, and resting pain are showing good results.

In addition a second trial is evaluating n=16 of n=20 patients with non-union or delayed union fracture of a long bone (tibia) who have undergone composite grafting with autologous bone marrow cell concentrate to evaluate the procedure's safety and effect on fracture healing. Long bone fractures represent an unmet medical need that the med tech companies have been chasing for years. So far the system has shown no intra-operative complications, and one non-device related adverse event. Of nine patients who are now out three-to-six months post-treatment, four have fractures that have united and four have experienced partial unions of the bone fracture which is quite hopeful.

Daily Dose Conclusion: Few are paying attention to KOOL as a therapeutic player in CLI or bone fractures and as a potential challenger to Cytori or even Aastrom or Pluristem in CLI. This is worth watching.

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Cytori (CYTX) : FDA Green Lights the Start of a Trial based on an IDE

Cytori Therapeutics (NASDAQ: CYTX) received an Investigational Device Exemption (IDE) approval from the U.S. FDA to start their Phase 1 trial; "ATHENA". ATHENA will investigate the use of the Celution® System, (this is the "bedside centrifuge" that processes stem cells from fat (adipose-derived stem and regenerative cells ADRCs) to treat a form of coronary heart disease, chronic myocardial ischemia (CMI).

This IDE approval comes pretty quickly given that the application was originally submitted to the FDA in December 2011.

ATHENA is a multi-center, randomized, double blind, placebo controlled, pilot trial to investigate the use of autologous, clinical-grade ADRCs, processed at the point-of-care with the Celution® System. The trial will enroll up to N=45 patients with no-option CMI who have limited therapeutic options.

It will evaluate a variety of clinical and functional outcomes, including safety, peak oxygen consumption (mVO2), and clinical outcomes at 12-months.

Previously, Cytori reported six and 18-month trial data from PRECISE, a European clinical trial for this same indication showing improvement in mVO2. In Europe, Cytori has applied to expand its Celution® System CE Mark to include no-option CMI claims based on data from the PRECISE trial. Cytori is also enrolling ADVANCE, a European pivotal trial investigating the Celution® System for acute myocardial infarction (heart attacks).

Daily Dose Take-Away: This is an exciting and interesting approach. If the trial shows strong efficacy signals it has big implications for the space. The key issues here will be:

• Understanding what the cell population here actually is ?
  
• What is its effective dose ?
  
• How is biologic variability accounted for ?
  

For example, Baxter has completed a PII trial in the same indication, but with an enriched population of marrow derived cells (CD 34+) ? So the cell type, the active ingredient, the dose, the timing and delivery are critical variables (to name a few) for a large indication like this one.

Cytori (CYTX) Publishes Apollo (P1/2a Heart Attack) Data

Cytori – (CYTX):  Publishes Appolo Results

Cytori Therapeutics (NASDAQ: CYTX) published previously reported six-month outcomes from their Apollo trial. This was an EU trial evaluating adipose (fat) derived stem cells (ADCs) in patients with acute myocardial infarction (heart attack or AMI).

Apollo was small at N=14-patients but it was a prospective, randomized, double-blind, placebo-controlled, feasibility trial (Phase I/IIA).

In the Apollo trial all patients were treated with standard-of-care and subsequently underwent an abdominal liposuction. Each patient's adipose tissue was processed by the Celution® System where ADRCs were extracted, washed and concentrated into a syringe of clinical grade cells. Within 36 hours of the myocardial infarction and no longer than 24 hours after undergoing percutaneous coronary intervention, patients received an injection of either 20 million ADRCs (n=10) or a placebo (n=4). Improvement in cardiac function by SPECT  and an improvement in blood flow  as well as a reduction in scar formation (infarct size).

Cytori claims that the “advantage of adipose tissue as a cell source is that it allows physicians to get a meaningful dose of a patient's own cells at the point-of-care when using the Celution® System without cell culture or use of donor cells". The paper’s author also states, "We believe delivering cells within the first 24 to 36 hours takes advantage of the body's signaling and initiates the repair process before irreparable damage occurs".

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