What is Bone?

  • Bone is an active living dynamic connective tissue.
  • Bones are semi-rigid, porous, mineralized organs, consisting of cells in a hard matrix, that form part of the endoskeleton

Anatomy of Bone

Bones consist of living cells embedded in a mineralized organic matrix. This matrix consists of organic components, mainly type I collagen – "organic" referring to materials produced as a result of the human body – and inorganic components, primarily hydroxyapatite and other salts of calcium and phosphate.

Characteristics of Bones

  • Bones undergo remodelling every 7 years.
  • Bones break only when they are subjected to extreme force or stress.
  • The most commonly broken bones are those in the wrist, hip, knee and ankle

Functions of Bones

  • Help in movement of the body
  • Provide support and protect the body
  • Produce red and white blood cells, and store minerals

Hip Joint

The hip joint is a ball and socket synovial joint, formed by an articulation between the pelvic acetabulum and the head of the femur. It forms a connection from the lower limb to the pelvic girdle, and thus is designed for stability and weight-bearing.

Importance of Hip Joint

  • The hip joint is one of the most important joints in the human body.
  • It allows us to walk, run, and jump. It bears our body's weight and the force of the strong muscles of the hip and leg.
  • The femur, or thighbone, is the longest and strongest bone in the body.

What is Avascular Necrosis (AVN) / Osteonecrosis (ON)?

Avascular necrosis (AVN) is the localized death of bone tissue as a result of injury (trauma), drug side effects, or a pre-existing disease.

  • Bone is a living tissue that requires continuous blood supply
  • Just like in heart attack, where lack of blood supply leads to death of heart muscle, ON arises due to lack of blood supply to the bone
  • ON commonly affects the upper part of the thigh bone or femoral head.
  • With no blood supply, bone tissue in the femoral head starts to deteriorate.
  • Gradual bone death leads to the break-down of the femoral head.

Causes of AVN/ ON

  • High-dose corticosteroid use
  • Alcohol abuse
  • Smoking
  • Trauma /accidents
  • Idiopathic

Risk factors for Osteonecrosis

  • Post Solid organ transplantation
  • Asthma
  • Cancer
  • Renal Failure
  • Inflammatory Bowel Disease
  • Systemic lupus erythematosus

Prevalence

  • Young population (20-40 age group)
  • US - 160,000 affected with ON
  • EU - 230,000 affected with ON
  • Without definitive treatment, 80% of all ON cases will progress within 3 years and inevitably undergo hip replacement
  • In more than 60% of the patients, both joints will be affected (bilateral)
  • On the basis of 2000-to-2014 data, primary total hip arthroplasty (THA) is projected to grow 71%, to 635,000 procedures, by 2030 in the US

Progression of Disease

  • Dead bone tissue does not function normally and leads to break-down of the affected joint.
  • After bone collapse, there is destruction of the cartilage joint adjacent to the affected bonethat leads to irreversible arthritic changes leading to severe pain.

Ficat and Arlet Classification System

Unmet Clinical need

Cell therapies are in use for cartilage repair .ACI involves harvesting a biopsy of the patients cartilage, isolating & expanding the cells and re-implanting them into the defect site.

What is Autologous Adult Live Cultured Osteoblasts?

  • Targeted and personalized bone cell therapy
  • Uses patients bone marrow as a source for bone making cells or osteoblasts
  • Formation of new bone preserves the structural-functional integrity of the joint
  • Femoral head is saved from breakdown or joint collapse
  • Eliminates need for Total Hip Arthroplasty
  • Patient is pain-free and returns to active normal life
  • Monetary burden from prospective surgeries lifted & Quality of life restored

Goal of Treatment

  • Initiate new blood supply
  • Remove dead bone
  • Form new bone
  • Stop progression of disease
  • In best case scenario complete reversal of disease

Need for Globally approved treatments for Joint Preservation

  • It is estimated that 70–80 % of osteonecrosis patients experience femoral head collapse, for which total hip arthroplasty is considered the most effective treatment, even in young patients
  • There is a crucial need for developing a minimally invasive regenerative therapy as a preventive surgery for femoral head collapse.
  • Core decompression, the most popular minimally invasive surgery for osteonecrosis of the femoral head, has been used for a long time; however, it has been insufficient to prevent femoral head collapse.

Case Reports

Our Process

Step 1

Bone Marrow Aspiration /Biopsy

 
  • A simple day-care procedure involving the extraction (biopsy) of a small quantity (4 ml) of your bone marrow will be performed. The procedure usually lasts for 10-15 minutes. The patient is usually given local anesthesia.
  • The bone marrow biopsy is aseptically transported under cold chain (low temperature) to a centralized GMP certified cell culture laboratory. Bone forming cells called osteoblasts are cultures within 14 -21 days.

Step 2

Osteoblast Implantation

Implantation Procedure:

  • The cultured cells (48 millions) are simply implanted onto the damaged area of the hip.
  • The implantation procedure usually lasts for about 30 – 45 minutes where, the patient is given spinal or general anesthesia. Patient returns home in about 2 days of time.
  • Through constantly guided physiotherapy including the muscle strengthening and load bearing capacity exercises, the new bone tissue formed becomes mechanically very robust allowing all activities as early as 6 months.

Billing and Insurance

  • Government purchases can be made through direct purchase option on www.gem.gov.in
  • All Regrow bills include transport and delivery kit charges.
  • Regrow invoice is submitted at time of biopsy to private institutions.
  • Regrow products are covered by all private and Govt.insurance schemes.

To place the order or to know more about the product, please call :

Dr. Charul Bhanji
Technical Director
 9821186618

Mr. Amos Chopade
Medical Officer
 9619835838

Medical Education

  • Publications
  • Presentations
  • Clinical Trial Summary

Please refer to our academic library for peer reviewed International Publications on ABI

Palekar G. Use of Autologous Mesenchymal Stem Cells inTreatment of Avascular Necrosis of the Hip- TechnicalReport and Results of a Case Study. Journal of Orthopedics and Rehabilitation. January 2011. 1(1): 99-101.
Shewale V, Vora M, Gupte S, Kalra R, Kansaria U, Vetiyattil M. AUTOLOGOUS OSTEOBLAST IMPLANTATION – A BOON TO BONEAUGMENTATION – A CASE REPORT. UJMDS 2014, 02 (01): 46-49
Hernigou P, Poignard A, Manicom O, Mathieu G, Rouard H. The use of percutaneous autologous bone marrow transplantation in nonunion and avascular necrosis of bone. The Journal of bone and joint surgery. British volume. 2005 Jul;87(7):896-902.
Gandhi Y, Shanbhag S, Sanghavi S, Bhanji C, Stavropoulos A. Autologous human osteoblasts for maxillofacial bone tissue engineering: ex vivo good manufacturing practice (GMP)-level expansion and clinical evaluation. Clinical Oral Implants Research. 2015 Sep 1;26.
Bhanji C, Ranka R, Arora R, Sanghavi S, Kedage V. Fibrous Dysplasia: A Case Report of Novel Treatment Approach. J Bone Res 2018, 6:2.
Deshmukh A, Kalra R, Chhadva S, Shetye A. Bilateral maxillary sinus floor augmentation with tissue‑engineeredautologous osteoblasts and demineralized freeze‑dried bone. Contemporary Clinical Dentistry Apr-Jun 2015; 6(2): 243-246
Kim SJ, Shin YW, Yang KH, Kim SB, Yoo MJ, Han SK, Im SA, Won YD, Sung YB, Jeon TS, Chang CH. A multi-center, randomized, clinical study to compare the effect and safety of autologous cultured osteoblast (Ossron™) injection to treat fractures. BMC musculoskeletal disorders. 2009 Dec;10(1):20.
Kim SJ, Bahk WJ, Chang CH, Jang JD, Suhl KH. Treatment of osteonecrosis of the femoral head using autologous cultured osteoblasts: a case report. Journal of medical case reports. 2008 Dec;2(1):58.
Sadat-Ali M, Azam MQ, Elshabouri EM, Tantawy AM, Acharya S. Stem Cell Therapy for Avascular necrosis of Femoral Head in Sickle cell disease: Report of 11 cases and Review of Literature. International journal of stem cells. 2017 Nov;10(2):179
Hauzeur JP, Toungouz M, Lechanteur C, Beguin Y, Baudoux É, De Maertelaer V, Pather S, Katz R, Ino J, Egrise D, Malaise M. Autologous osteoblastic cells (PREOBy) versus concentrated bone marrow implantation in osteonecrosis of the femoral head: A randomized study. Revue de ChirurgieOrthopédique et Traumatologique. 2016 Nov 1;102(7):S73

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