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Past Research

Past Research

Our preliminary work was essentially a pilot study in humans performed with IRB approval. We were not looking for clinical efficacy. However, secondary endpoints such as improvement in their conditions were certainly optimistic and have acted as a catalyst for our move to a phase 1/2 trial with the FDA.

Pre-FDA work with stromal vascular fraction (SVF): 33 Patients with various incurable, recalcitrant to all attempted therapies, neurodegenerative diseases had a total of 151 injections with a 3.5-year follow-up. There were minor adverse events (treated and resolved):

Click Here to Read RBI’s White Paper

Reservoir AEs (per 151 injections):

  • Infection: 0
  • Headache: 2
  • Fever: 0
  • Meningismus: 2
  • Reservoir Malfunction/infection: 2 (replaced)
  • Clinical Adverse Events (treated and resolved – per 151 injections):

  • Infection: 1
  • Transient Headache: 23
  • Transient Fever: 18
  • Acute Hydrocephalus: 1
  • Transient Meningismus: 23
  • For the neurodegenerative diseases we are targeting, there are currently no real effective therapies. Our revolutionary direct-injection stem cell therapy offers patients suffering from Alzheimer’s disease, ALS, and Multiple sclerosis, a new approach. The following are some of our clinical efficacy results.

    Fig. 1 below shows the bad Tau protein, P-Tau, diminishing, in injected Alzheimer’s patients

    Fig. 2 below shows the injection technique

    Fig. 3 below shows one of our Alzheimer’s patients exhibiting actual growth of the hippocampus, the “short-term memory area of the brain”

    Fig. 1

    Fig. 2

    Fig. 3

    Alzheimer’s Disease: 12 Treated

    • 5 not declining and getting better
    • 6 not declining
    • 1 worse, since stopping treatment

    Multiple Sclerosis: 6 Treated

    • 3/6 subjects improving
    • 3/6 not declining

    Traumatic Brain Injury: 1 Treated

    • 1/1 subject improving

    A Typical Result for One of Our Alzheimer's Patients