NCT01182337

A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

Completed Phase 1/Phase 2 Results posted Last updated 26 January 2016

What this trial tests

Phase 1/Phase 2 trial testing Intradiscal rhGDF-5 in Early Lumbar Disc Degeneration in 31 participants. Completed in 1 June 2014.

Timeline

1 June 2010

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	DePuy Spine
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Enrollment	31
Start date	1 June 2010
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	7 locations across South Korea

Drugs / interventions tested

• Intradiscal rhGDF-5 — full drug profile →
• Vehicle control — full drug profile →

Conditions studied

• Early Lumbar Disc Degeneration — all drugs for Early Lumbar Disc Degeneration →

Sponsor

DePuy Spine — full company profile →

Who can join

18 and older, any sex, with Early Lumbar Disc Degeneration. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Neurological Assessment for Motor Function and Reflexes/Sensory
  Time frame: 12 months
  Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against
• Treatment Emergent Adverse Events- Relationship to Study Drug
  Time frame: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
  Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.
• Treatment Emergent Adverse Events- Relationship to Study Drug
  Time frame: 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
  Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.

Sponsor's own description

Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intervertebral Disc Degeneration: Biomaterials and Tissue Engineering Strategies toward Precision Medicine.
   Mohd Isa IL, Mokhtar SA, Abbah SA, Fauzi MB, et al · · 2022 · cited 101× · PMID 35373924 · DOI 10.1002/adhm.202102530
2. Intervertebral disc degeneration-Current therapeutic options and challenges.
   Samanta A, Lufkin T, Kraus P. · · 2023 · cited 98× · PMID 37483952 · DOI 10.3389/fpubh.2023.1156749
3. Strategies for Annulus Fibrosus Regeneration: From Biological Therapies to Tissue Engineering.
   Chu G, Shi C, Wang H, Zhang W, et al · · 2018 · cited 76× · PMID 30042942 · DOI 10.3389/fbioe.2018.00090
4. Intervertebral Disc Nucleus Repair: Hype or Hope?
   Tendulkar G, Chen T, Ehnert S, Kaps HP, et al · · 2019 · cited 54× · PMID 31344903 · DOI 10.3390/ijms20153622
5. Potential regenerative treatment strategies for intervertebral disc degeneration in dogs.
   Bach FC, Willems N, Penning LC, Ito K, et al · · 2014 · cited 46× · PMID 24387033 · DOI 10.1186/1746-6148-10-3
6. Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical.
   Thorpe AA, Bach FC, Tryfonidou MA, Le Maitre CL, et al · · 2018 · cited 43× · PMID 31463447 · DOI 10.1002/jsp2.1027
7. Development, Pathogenesis, and Regeneration of the Intervertebral Disc: Current and Future Insights Spanning Traditional to Omics Methods.
   Hickman TT, Rathan-Kumar S, Peck SH. · · 2022 · cited 40× · PMID 35359439 · DOI 10.3389/fcell.2022.841831
8. Recent Advances in Managing Spinal Intervertebral Discs Degeneration.
   Costăchescu B, Niculescu AG, Teleanu RI, Iliescu BF, et al · · 2022 · cited 38× · PMID 35742903 · DOI 10.3390/ijms23126460