Osteoarthritis

PlenaStem™ for OA

(formerly AugmenStem™ )

At AVM Biotechnology, we are dedicated to halting progression of the disease and improving daily quality of life and function.

Clinical use of stem cells as regenerative therapy for musculoskeletal conditions and specifically, as a treatment for knee OA, has recently grown in popularity and is supported by evidence from clinical studies (Cui 2016; Kristjannsen 2014; Shapiro 2017; Veronesi 2013; Wong 2013). Stem cell therapy has provided benefits for OA, but the benefits have not been complete nor permanent.

A single oral dose of PlenaStem™ can dramatically enhance and maintain the benefits of stem cell treatment PlenaStem™ has issued and pending worldwide patents to provide exclusivity as well as freedom to operate.

PlenaStem™ pre-treatment will make your stem cell product the most effective and sought after on the market. We are seeking stem cell or device partners to develop and commercialize our lead product PlenaStem™ worldwide for musculoskeletal and other diseases.

Our R&D Pipeline

At AVM, we will unleash the potential of stem cell therapy, allowing breakthroughs in regenerative medicine. PlenaStem™ for knee OA will soon be evaluated in Phase IIb clinical trials. Below is our R&D pipeline.

Discovery & Lead ValidationComplete
Optimization & FormulationComplete
Efficacy & Safety - In Vitro & In VivoComplete
IND ApplicationIn Process
Phase I Clinical TrialsData Available
The Problem
Osteoarthritis

OA is a progressive degenerative disease that causes increasing pain, impairment and disability. Half of the world’s population aged 65 years or older has OA. Statistically, it is the most prevalent disorder of articulating joints in humans.

In OA of the knee, the cartilage in the knee joint gradually wears away and becomes frayed and rough, and the buffering space between the bones decreases. This can lead to bone rubbing on bone and produce painful bone spurs. Symptoms include stiffness, pain, inflammation, and creaking noises in the joint.

Currently available treatments for knee OA

While the available treatments seek to alleviate pain or improve mobility, these treatments rarely stop the progression of the disease or regenerate damaged cartilage. For knee OA, the American College of Rheumatology (ACR) and American Academy of Orthopedic Surgeons (AAOS) guidelines recommend using Oral NSAIDs, Topical NSAIDs, and Tramadol which unfortunately have undesirable side effects.

Remarkable Effects of PlenaStem™ on Horse Patients

The horse has been used as a model for knee OA because of their close similarity to human joints (Gregory 2012). Collaborating with Regeneus Ltd. in Australia and Rood & Riddle Equine Hospital in Lexington, KY, AVM treated 11 horse patients; the results were outstanding and demonstrated a great safety and efficacy profile for PlenaStem™. Most importantly, no adverse events were noted in any of the treated horses, followed for as long as 2.5 years.

Improvement in Tendon Injury Repair

AVM treated dressage horse BB for tendon injury with a 48-hour pre-treatment with PlenaStem™, followed by allogeneic adipose-derived mesenchymal stem cells (MSC). Notable recovery at 1 month. Back to light work in 6 months.
Stem Cells Alone
Horses typically require 3-6 months for recovery.
Stem Cells + PlenaStem™
Significant recovery observed at 1 month.

Improvement in Advanced Osteoarthritis

AVM treated dressage horse Jigsaw R for OA with a 48-hour pre-treatment with PlenaStem™, followed by allogeneic adipose-derived mesenchymal stem cells (MSC). Jigsaw R was previously placed 7th in The Riders Shoppe Six Year Old Young Horse Qualifier.
Stem Cells Alone
Horses typically require 3-6 months for recovery.
Stem Cells + PlenaStem™
Significant recovery observed at 1 month.

Safety and Biodistribution Horse Data

Case # Gender/Age Condition Treatment Response Results
EQ-101 Mare/NA Old mare with OA in multiple joints; pilot study case 6mg/kg of PlenaStem™ (IV) Well tolerated; no side effects noted No infections, no laminitis, no Cushing’s syndrome
EQ-102 Young mare race horse with OA in one joint; pilot study case No infections, no laminitis, liver enzymes tested normal
EQ-104 Mare/8 Normal mare without OA High dose well tolerated
EQ-109 Mare/NA Normal mares without OA; Stem cell (SC) biodistribution study Labeled allogeneic adipose MSC (IA) Peak number of synovial MSC detected at 15 min. Elimination of synoval MSC evident by 4-8 hours
EQ-110 Labeled allogeneic adipose MSC (IA)

 

Safety and Efficacy Horse Data

Case # Gender/Age Condition Treatment Response Results
EQ-103 Mare/NA Normal mare with OA 3mg/kg of PlenaStem™(IV); allogeneic adipose mesenchymal SC (IA) Well tolerated; no side effects noted Improvement in treated joints
EQ-105 Gelding/35 OA; advanced degenerated joint disease in the pasterns, hocks and knees 6mg/kg of PlenaStem™(IV); allogeneic adipose mesenchymal SC (IA) Less pain in flexion of carpi; lameness in fore/hindlimbs improved by 1 whole grade
EQ-106 Mare/6 Normal mare without OA 3mg/kg of PlenaStem™(IV); allogeneic adipose mesenchymal SC (IA) Improvement in treated joints; back to dressage training* in 4 months
EQ-107 Gelding/8 Improvement in treated joints
EQ-108 Gelding/14 Tendon injury (DDFT) grade 3 Remarkable improvement observed at 3 weeks, back to light work* in 6 months instead of 12
EQ-111 Mare/15 months OA; congenital OCD 3 lesions, right hock, 3 prior surgeries (partial response) Expanded autologous bone marrow MSC (Intra-articular injection) Lameness eliminated in 2 weeks