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LOW BACK PAIN
Degenerative Disc Disease and Low back pain:

Degenerative disc disease is the leading cause of chronic Low Back Pain. The ageing process, repetitive minor trauma or major trauma may lead to internal disc disruption and this, in turn, initiates the process of degenerative disc disease. Internal disc disruption or fissure is characterized by degradation of the nuclear matrix and the development of fissure in the disc1.

Up to 84% of the US adult population suffer from low back pain sometime in their lives and over 1 in 4 of the US adult reports recent history of low back pain( in the last 3 months). Low back pain is costly: Total US healthcare expenditure for low back pain in 1998 were estimated at $ 90 billion.

Ref: AHRQ Publication No. 16-EHC004-EF February 2016.

This is a Phase I, first in human, randomized, double-blind, vehicle and placebo-controlled, parallel group, multi-center study in subjects with single level, symptomatic lumbar intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with two control groups (saline, Sodium Hyaluronate).

IDCT is a mixture of allogeneic progenitor cells in hyaluronic acid and other ingredients. These allogenic progenitor cells are livediscogenic cells generated from adult intervertebral disc tissue. The investigational product will be injected once into painful, moderately degenerated intervertebral discs. Laboratory evaluation of discogenic cells shows that they lack markers that will trigger an immune reaction and also do not form tumors. Based on preclinical evaluation of IDCT, the proposed mechanisms of action are as follows:

1. The discogenic cells are likely to generateproteoglycan and collagen, which are the building blocks of disc cartilage.

2. The discogenic cells are likely to generate a local anti-inflammatory milieu, which can directly modify pain sensation.

Based on these findings, it is hypothesized that the investigational product may reduce pain and disability associated with disc degeneration. Other outcomes such as reduction in pain medication usage and time to subsequent intervention will also be evaluated in this clinical study, which is overseen by the FDA through an Investigational New Drug (IND) application.
7 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 72 and week 104. The subject will be assessed for safety and efficacy utilizing VAS and ODI questionnaires alongside radiographic evaluations. The study will have a 1-year follow-up and a 1 year extension period (total 2 years).

Inclusion Criteria :
The subject must have:
  1. Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7.

  2. Chronic low back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care.

  3. Low back pain of 40 to 90 mm on the VAS and ODI score of 30 to 90.

Exclusion Criteria :
The subject is excluded if he/she has
  1. Symptomatic involvement of more than one lumbar disc.

  2. Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.

  3. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.

  4. Evidence of dynamic instability on lumbar flexion-extension radiographs.

  5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc.

  6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology.

  7. Clinical suspicion of facet pain as primary pain generator.

  8. Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection.

  9. Patient who are deemed unsuitable for clinical study participation by the investigator.

How discogenic low back pain is caused?
Initially the fissure is radial and then it may extend circumferentially in the annulus. Grade III is when the fissure or tear extends for 2/3rd of the annulus (outer third layer of the disc). Grade III tear causes most of the pain. Normally, Grade I, II tear is not associated with pain. Stress profilometry is a study in which a probe is used to measure stress across the disc. In a normal disc, stresses across are uniform. However, in painful degenerative discs with tear, the stress is reduced in the center of the disc, but it is significantly increased in the posterior portion of the disc leading to tear or fissure50. The increased pressure in the posterior disc causes protrusion and intradiscal tear. Protrusion causes mechanical pain and tear causes chemical sensitivity (chemical nociception) 52by releasing chemicals (cytokines), which cause immense inflammation leading to muscle spasm and pain.

Trauma (major or repetitive minor) leads to fracture of Endplates. This also triggers chemical process in the nucleus leading to loss of water, reduction of nuclear pressure, increasing pressure in the posterior of the disc causing pain. These changes lead to cell death of the cartilage.

Normal Anatomy of disc:



Stages of Disc Degeneration leading to disc herniation:

Current treatment options of painful degenerative disc disease are:

  1. Anti-inflammatory medicine
  2. Muscle Relaxants
  3. Antiseizure medicine
  4. Opioid Medicine
  5. Physical Therapy
  6. Chiropractic treatment
  7. Yoga
  8. TENS unit
  9. Spine Injections, such as Epidural steroid injections, Facet joint block
  10. Spinal Cord Stimulation, Morphine pump
  11. Surgery (discectomy, instrumented fusion, laser assisted surgery etc.)

Significant number of patient continues to suffer from back pain despite all these intervention. Chronic use of anti-inflammatory medication results in high blood pressure, kidney failure, GERD etc. Opioids are inherently risky because of its addiction causing property. Surgery has a high failure rate.

Consequently a lot of patients seek for alternative and at times unproven treatment for seeking relief from pain.



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LOW BACK PAIN
Degenerative Disc Disease and Low back pain:

Degenerative disc disease is the leading cause of chronic Low Back Pain. The ageing process, repetitive minor trauma or major trauma may lead to internal disc disruption and this, in turn, initiates the process of degenerative disc disease. Internal disc disruption or fissure is characterized by degradation of the nuclear matrix and the development of fissure in the disc1.

Up to 84% of the US adult population suffer from low back pain sometime in their lives and over 1 in 4 of the US adult reports recent history of low back pain( in the last 3 months). Low back pain is costly: Total US healthcare expenditure for low back pain in 1998 were estimated at $ 90 billion.

Ref: AHRQ Publication No. 16-EHC004-EF February 2016.

This is a Phase I, first in human, randomized, double-blind, vehicle and placebo-controlled, parallel group, multi-center study in subjects with single level, symptomatic lumbar intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with two control groups (saline, Sodium Hyaluronate).

IDCT is a mixture of allogeneic progenitor cells in hyaluronic acid and other ingredients. These allogenic progenitor cells are livediscogenic cells generated from adult intervertebral disc tissue. The investigational product will be injected once into painful, moderately degenerated intervertebral discs. Laboratory evaluation of discogenic cells shows that they lack markers that will trigger an immune reaction and also do not form tumors. Based on preclinical evaluation of IDCT, the proposed mechanisms of action are as follows:

1. The discogenic cells are likely to generateproteoglycan and collagen, which are the building blocks of disc cartilage.

2. The discogenic cells are likely to generate a local anti-inflammatory milieu, which can directly modify pain sensation.

Based on these findings, it is hypothesized that the investigational product may reduce pain and disability associated with disc degeneration. Other outcomes such as reduction in pain medication usage and time to subsequent intervention will also be evaluated in this clinical study, which is overseen by the FDA through an Investigational New Drug (IND) application.
7 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 72 and week 104. The subject will be assessed for safety and efficacy utilizing VAS and ODI questionnaires alongside radiographic evaluations. The study will have a 1-year follow-up and a 1 year extension period (total 2 years).

Inclusion Criteria :
The subject must have:
  1. Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7.

  2. Chronic low back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care.

  3. Low back pain of 40 to 90 mm on the VAS and ODI score of 30 to 90.

Exclusion Criteria :
The subject is excluded if he/she has
  1. Symptomatic involvement of more than one lumbar disc.

  2. Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.

  3. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.

  4. Evidence of dynamic instability on lumbar flexion-extension radiographs.

  5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc.

  6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology.

  7. Clinical suspicion of facet pain as primary pain generator.

  8. Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection.

  9. Patient who are deemed unsuitable for clinical study participation by the investigator.

How discogenic low back pain is caused?
Initially the fissure is radial and then it may extend circumferentially in the annulus. Grade III is when the fissure or tear extends for 2/3rd of the annulus (outer third layer of the disc). Grade III tear causes most of the pain. Normally, Grade I, II tear is not associated with pain. Stress profilometry is a study in which a probe is used to measure stress across the disc. In a normal disc, stresses across are uniform. However, in painful degenerative discs with tear, the stress is reduced in the center of the disc, but it is significantly increased in the posterior portion of the disc leading to tear or fissure50. The increased pressure in the posterior disc causes protrusion and intradiscal tear. Protrusion causes mechanical pain and tear causes chemical sensitivity (chemical nociception) 52by releasing chemicals (cytokines), which cause immense inflammation leading to muscle spasm and pain.

Trauma (major or repetitive minor) leads to fracture of Endplates. This also triggers chemical process in the nucleus leading to loss of water, reduction of nuclear pressure, increasing pressure in the posterior of the disc causing pain. These changes lead to cell death of the cartilage.

Normal Anatomy of disc:



Stages of Disc Degeneration leading to disc herniation:

Current treatment options of painful degenerative disc disease are:

  1. Anti-inflammatory medicine
  2. Muscle Relaxants
  3. Antiseizure medicine
  4. Opioid Medicine
  5. Physical Therapy
  6. Chiropractic treatment
  7. Yoga
  8. TENS unit
  9. Spine Injections, such as Epidural steroid injections, Facet joint block
  10. Spinal Cord Stimulation, Morphine pump
  11. Surgery (discectomy, instrumented fusion, laser assisted surgery etc.)

Significant number of patient continues to suffer from back pain despite all these intervention. Chronic use of anti-inflammatory medication results in high blood pressure, kidney failure, GERD etc. Opioids are inherently risky because of its addiction causing property. Surgery has a high failure rate.
Consequently a lot of patients seek for alternative and at times unproven treatment for seeking relief from pain.
At Otrimed Clinical research, we are conducting two ground breaking research for treating low back pain.


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