Jul 31, 2020

FDA Approved Stem Cell Clinical Trial for COVID-19

Posted by Bob under COVID-19, Stem Cell Therapy

It is with immense pride that we announce our human company, Personalized Stem Cells, recently received FDA approval to treat COVID-19 patients in an upcoming clinical trial. Read PSC’s blog below:

Personalized Stem Cells (PSC) recently received FDA approval to treat COVID-19 patients with stem cells in an upcoming clinical trial. In April, we announced that we filed an expedited IND at the request of the White House Coronavirus Task Force to treat hospitalized COVID-19 patients. This approval is incredibly significant because patients will be treated with disease-screened, quality tested donor cells as opposed to their own stem cells. This is known as allogeneic stem cell therapy and is different from PSC’s current FDA approved clinical trial in which patients receive their own stem cells (autologous) to treat knee osteoarthritis.

Stem Cell Therapy for COVID-19

PSC has become a leader in the field, recently publishing a landmark peer-reviewed scientific article on the rationale behind using stem cells to treat COVID-19. Mesenchymal stem cells (MSCs) have demonstrated the capacity to inhibit lung damage, reduce inflammation, dampen immune responses and aid with alveolar fluid clearance. Additionally, MSCs produce molecules that are antimicrobial and reduce pain. Recently, the application of MSCs in the context of ongoing COVID-19 disease and other viral respiratory illnesses has demonstrated reduced patient mortality and, in some cases, improved long-term pulmonary function.

Based on information out of Israel, China, Spain and the United States, stem cells have shown promising effectiveness in the treatment of the major medical lung issues caused by COVID-19. Israel recently announced 100% recovery in seven COVID-19 patients who were treated with stem cell therapy. Spanish medical investigators reported on an adipose stem cell study in which 13 COVID-19 patients were treated using a protocol very similar to the one just approved for PSC. According to the results, the mortality rate in the treated patients was significantly decreased.

FDA Approved Clinical Trial: CoronaStem 1

The initial clinical trial, named CoronaStem 1, will include 20 COVID-19 patients hospitalized in California. Once complete, PSC hopes to move into a larger Phase 2 clinical study and potentially into FDA Expanded Use programs or Emergency Use Authorization, which could allow for many more patients to be treated.

In order to rapidly ramp up the production of stem cells for use in the clinical trial, PSC collaborated with Calidi Biotherapeutics, a biotechnology company based in San Diego, California. Calidi provided disease-screened, quality stem cell lines to PSC, enabling us to accelerate the stem cell drug manufacturing process. In addition, sister company and CRO, VetStem Biopharma, provided manufacturing and regulatory support to help make FDA approval a reality.

PSC is not currently soliciting patients for inclusion in CoronaStem 1 due to the limited number of hospitals participating in the study. For more information regarding future clinical trials, please contact us here.

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Dec 1, 2011

Global Leaders in Stem Cell Therapy Meet in La Jolla

Posted by Bob under Stem Cell Industry

Yesterday a global stem cell meeting began in La Jolla with leaders from around the world, “Stem Cells on the Mesa.”  The discussions are centered on stem cell science and the development of new products.  Vet-Stem presented the stem cell story in veterinary medicine to the amazement of many in the audience.  Researchers and business leaders commented that Vet-Stem and veterinary medicine were leaders in translating stem cell science into true clinical treatments.  With over 4000 horses and 4000 dogs treated with stem cells, we are helping the industry see that stem cell therapy really works and is safe! Read the rest of this entry »

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Nov 6, 2009

How do you tell if your pet has OA?

Posted by Bob under Dog Arthritis
  • Do they limp?
  • Are they less active, sleeping more often, not interested in normal routines?
  • Are they reluctant to jump up on the bed or into the car?
  • Do they sleep less and circle a lot to get comfortable when lying down?
  • Do they have difficulty getting up from a “sit” or a “lie down”?
  • Do they have muscle atrophy?
  • Stand over your dog looking down on his spine- do you see the front end of your dog well developed while the back end has gotten skinny?
  • Do they lick the top of their paws?
  • Do they lack stamina on walks? i.e Used to walk a mile every night, now 3 blocks is their limit
  • Do you feel and hear crackling and popping in your dog’s joints?

These signs could mean that your dog has arthritis. Your veterinarian can confirm a diagnosis of OA with a good physical examination, a good lameness examination and x-rays. Note I separated out the physical exam from the lameness. The physical exam encompasses the total animal, but the lameness is about their gait, stride, range
of motion, and joint pain tolerance.

Have you discussed options for treating arthritis with your veterinarian?

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