Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Chronic Renal Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by International Stemcell Services Limited.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
International Stemcell Services Limited
ClinicalTrials.gov Identifier:
NCT01152411
First received: June 26, 2010
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

Chronic renal failure (CRF, or "chronic kidney failure", CKF, or "chronic kidney disease", CKD) is a slowly progressive loss of renal function over a period of months or years and defined as an abnormally low glomerular filtration rate, which is usually determined indirectly by the creatinine level in blood serum.

CRF that leads to severe illness and requires some form of renal replacement therapy(such as dialysis) is called end-stage renal disease (ESRD). While renal replacement therapies can maintain patients indefinitely and prolong life, the quality of life is severely affected. Renal transplantation increases the survival of patients with stage 5 CKD significantly when compared to other therapeutic options; however, it is associated with an increased short-term mortality (due to complications of the surgery).

In view of the above, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully hence the inadequacy of current treatment modalities and insufficiency of donor organs for transplantation have driven a search for improved methods of dealing with renal failure. The rising concept of cell-based therapeutics has provided a framework around which new approaches are being generated, and its combination with advances in stem cell research stands to bring both fields to clinical fruition. Since CRF affects a large number of these patients who will lose their productive life, stem cell implantation can offer some promise of improved health.

In our present study, we want to evaluate the safety and efficacy (to know / observe for Proof of concept in five indian patients) if any, of autologous bone marrow derived stem cells injected into the Renal Artery in five (initially five patients, can be increased to ten patients after observing the initial results) patients with Chronic Renal Failure.


Condition Intervention Phase
Chronic Renal Failure
Other: Autologous bone marrow stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Autologous Bone Marrow Stem Cell Transplantation in the Treatment of Chronic Renal Failure in 5 Indian Patients - ABMST-CRF Study (Autologous Bone Marrow Stem Cell Transplantation-CRF)

Resource links provided by NLM:


Further study details as provided by International Stemcell Services Limited:

Primary Outcome Measures:
  • Significant clinical improvement in serum creatinine and urine output (improvement in measured GFR by 50%) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of patients reporting adverse effects as a measure of safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in renal biopsy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: February 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous bone marrow stem cells Other: Autologous bone marrow stem cells
Bone marrow stem cells; Single dose; Interventional fluoroscopy-guided injection into the renal artery.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be able to give voluntary written (patients may not be able to write) consent.
  2. Must be able to understand study information provided to him.
  3. CKD patients of stage IV and ESRD with age 18 to 65 years.
  4. Patient should be afebrile 24 hours prior to procedure.

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Acute Renal Failure
  • Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
  • Haemoglobin level below 8g %
  • Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
  • Known bleeding or coagulation disorder.
  • Known hematologic disease
  • Poorly controlled hypertension
  • Evidence of active malignancy within one year prior to randomization.
  • Severe skin infection or osteomyelitis - the site of bone marrow aspiration potentially limiting the procedure.
  • Have a known allergy to iodinated contrast
  • Positive test results for HIV and AIDS complex, HCV, HbsAg and Syphilis.
  • History of drug or alcohol abuse
  • Patients on immunosuppressive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152411

Locations
India
St. Theresa's Hospital
Bengaluru, Karnataka, India, 560010
Sponsors and Collaborators
International Stemcell Services Limited
Investigators
Study Director: Balakrishna S, M.B.B.S International Stemcell Services Limited
  More Information

No publications provided

Responsible Party: International Stemcell Services Limited
ClinicalTrials.gov Identifier: NCT01152411     History of Changes
Other Study ID Numbers: ISSL-AuBM-CRF
Study First Received: June 26, 2010
Last Updated: March 28, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by International Stemcell Services Limited:
Renal Failure
Chronic Kidney Disease
Chronic Renal Failure

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 18, 2014